Task [documentation R4 R5 R6]
id: 0f1151bfbd9ef345f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52
- Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission TypeCode: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Identifier: XX/H/0029/21213/123 (http://ema.europa.eu/fhir/applicationIdentifierNumber)
Status: requested
Intent: order
Date: from 2024-01-16
Focus:
Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Focus:
Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Focus:
Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Date: Next Production Run/Next Printing - true
Implementation Date Comment: Or a similar date
Task [documentation R4 R5 R6]
id: variation-9d8af4f33aaa0245f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/variation-9d8af4f33aaa0245f8d69a306efd3c52
- A.3 - ADMINISTRATIVE CHANGES - Change in name of the active substance or of an excipient [100000152175] (https://spor.ema.europa.eu/v1/lists/100000152091) - Variation Classification - Text: A.3Code: A.3 - ADMINISTRATIVE CHANGES - Change in name of the active substance or of an excipient [100000152175] (https://spor.ema.europa.eu/v1/lists/100000152091) - Variation Classification - Text: A.3
Identifier: A.3 - Variation Type IB - 1 (http://ema.europa.eu/fhir/scopeIdentifier)
Status: requested
Intent: order
Input
Type: Art. 5 [200000027910] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: false
Input
Type: Procedure Type [200000027906] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Input
Type: For veterinary medicinal products for food-producing species, the new name has been published in Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. [200000003814] (https://spor.ema.europa.eu/v1/lists/200000003554) - Conditions
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Condition Applies: true
Input
Type: Proof of acceptance by WHO or copy of the INN list. If applicable, proof that the change is in line with the Ph. Eur. For herbal medicinal product, declaration that the name is in accordance with the Note for Guidance on Quality of Herbal Medicinal Products, and with the guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products. [200000004351] (https://spor.ema.europa.eu/v1/lists/200000003964) - Documentation
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Documentation Applies: true
Input
Type: Revised product information. [200000004368] (https://spor.ema.europa.eu/v1/lists/200000003964) - Documentation
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Documentation Applies: true
Input
Type: The active substance/excipient must remain the same. [200000003780] (https://spor.ema.europa.eu/v1/lists/200000003554) - Conditions
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Condition Applies: true
Task [documentation R4 R5 R6]
id: variation-b26ba9e03aaa0519f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/variation-b26ba9e03aaa0519f8d69a306efd3c52
- A.1 - ADMINISTRATIVE CHANGES - Change in the name and/or address of the marketing authorisation holder [100000152170] (https://spor.ema.europa.eu/v1/lists/100000152091) - Variation Classification - Text: A.1Code: A.1 - ADMINISTRATIVE CHANGES - Change in the name and/or address of the marketing authorisation holder [100000152170] (https://spor.ema.europa.eu/v1/lists/100000152091) - Variation Classification - Text: A.1
Identifier: A.1 - Variation Type IB - 1 (http://ema.europa.eu/fhir/scopeIdentifier)
Status: requested
Intent: order
Input
Type: Art. 5 [200000027910] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: false
Input
Type: Procedure Type [200000027906] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Input
Type: A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name and/or address is mentioned. [200000004212] (https://spor.ema.europa.eu/v1/lists/200000003964) - Documentation
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Documentation Applies: true
Input
Type: Revised product information. [200000004368] (https://spor.ema.europa.eu/v1/lists/200000003964) - Documentation
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Documentation Applies: true
Input
Type: The marketing authorisation holder shall remain the same legal entity. [200000003872] (https://spor.ema.europa.eu/v1/lists/200000003554) - Conditions
Value:
[valueString in Task.input is deprecated for eAF] (no text)
Condition Applies: true
Input
Type: Procedure Type [200000027906] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Input
Type: Domain [200000027903] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: Human use [100000000012] (https://spor.ema.europa.eu/v1/lists/100000000004) - Domain
Input
Type: Type of Application [900000000759] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: Grouped Regulatory Activity [100000155555] (https://spor.ema.europa.eu/v1/lists/100000155553) - Submission Mode
Input
Type: Including a line extension [200000027904] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: false
Input
Type: worksharing/procedureDetailType [100000155556] (https://spor.ema.europa.eu/v1/lists/100000155553) - Submission Mode
Value: true
Input
Type: IG - grouping of type IA variations [200000027905] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: false
Input
Type: Precise scope for change [200000027908] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Content Type: text/html
Value: Base64 (text/html): PGRpdiBkYXRhLXdyYXBwZXI9InRydWUiIHN0eWxlPSJmb250LWZhbWlseTonU2Vnb2UgVUknLCdIZWx2ZXRpY2EgTmV1ZScsc2Fu (truncated)
Value HTML:
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Lorem Medica Ipsum
Lorem medica ipsum dolor sit amet, consectetur adipiscing elit. Sed pharetra vitae justo vitae tincidunt. Proin vitae feugiat metus. Quisque ac lectus eu augue pellentesque euismod. Nullam sed neque vitae justo eleifend tempor. Duis vel elit eget turpis bibendum auctor.
Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Ut vel enim et lacus suscipit aliquam. Nunc euismod ex ac urna lobortis, eget suscipit justo varius.
Input
Type: Background [200000027909] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Content Type: text/html
Value: Base64 (text/html): PGRpdiBkYXRhLXdyYXBwZXI9InRydWUiIHN0eWxlPSJmb250LWZhbWlseTonU2Vnb2UgVUknLCdIZWx2ZXRpY2EgTmV1ZScsc2Fu (truncated)
Value HTML:
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Curabitur eget convallis orci.
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In hac habitasse platea dictumst. Ut euismod nisi vitae mi volutpat, ac sodales elit dignissim. Aenean ut tellus quis elit aliquet venenatis. Sed bibendum dolor vel dui lobortis, id volutpat elit auctor. Sed vel hendrerit risus.
Input
Type: Other applications [200000027907] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value:
AT/H/0024/1215/523 [valueString in Task.input is deprecated for eAF]
Input
Type: Indication [200000027947] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Paediatric requirements [200000027948] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Safety [200000027949] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Following urgent safety restriction [200000027950] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Quality [200000027951] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Annual variation for human influenza vaccines [200000027952] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: true
Input
Type: Variation to changes related to the active substance of a human coronavirus vaccine [200000027953] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Medical devices [200000027954] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: true
Input
Type: Non-food producing target species [200000027955] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Other [200000027956] (https://spor.ema.europa.eu/v1/lists/200000027936) - Changes concerned in type IB and type II variations
Value: false
Input
Type: Annexed Documents [100000155533] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Reference
Found a parent (Task/valueReference, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Document [documentation R4 R5 R6]which is linked to this by resource.id
id: BATCH
fullUrl: https://ema.europa.eu/fhir/fullUrl/DocumentReference/BATCH
Status: current
Type: Annexed Documents [100000155533] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Content
(Data Absent Reason: unknown)
Display: Annex II
Input
Type: Annexed Documents [100000155538] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Reference
Found a parent (Task/valueReference, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Document [documentation R4 R5 R6]which is linked to this by resource.id
id: PIL
fullUrl: https://ema.europa.eu/fhir/fullUrl/DocumentReference/PIL
Status: current
Type: Annexed Documents [100000155538] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Content
(Data Absent Reason: unknown)
Display: Package Leaflet
Input
Type: Annexed Documents [200000027914] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Reference
Found a parent (Task/valueReference, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Document [documentation R4 R5 R6]which is linked to this by resource.id
id: SPEC
fullUrl: https://ema.europa.eu/fhir/fullUrl/DocumentReference/SPEC
Status: current
Type: Annexed Documents [200000027914] (https://spor.ema.europa.eu/v1/lists/100000155531) - Product Information Document Type
Content
(Data Absent Reason: unknown)
Display: Specimens
Input
Type: There are no other changes than those identified in this application (except for those addressed in other variations submitted in parallel); [200000027822] (https://spor.ema.europa.eu/v1/lists/200000027815) - Variation Declaration
Value: true
Input
Type: For type IA notifications: the required documents as specified for the changes concerned have been submitted; [200000027824] (https://spor.ema.europa.eu/v1/lists/200000027815) - Variation Declaration
Value: true
Input
Type: All PIs (including annotated PIs are submitted in an anonymised format (i.e. names of the reviewers removed from the track-changes, no names in document properties and other parts of the documents) [200000027967] (https://spor.ema.europa.eu/v1/lists/200000027815) - Variation Declaration
Value: true
Input
Type: The individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other marketing authorisation applicants, marketing authorisation holders and National Competent Authorities, as relevant [200000027969] (https://spor.ema.europa.eu/v1/lists/200000027815) - Variation Declaration
Value: true
Input
Type: I understand that EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the marketing authorisation holder [200000027968] (https://spor.ema.europa.eu/v1/lists/200000027815) - Variation Declaration
Value: true
Input
Type: Same variation other members [200000027913] (https://spor.ema.europa.eu/v1/lists/200000027891) - Procedure Detail Type
Value: false
For
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency
Requested by
Role [documentation R4 R5 R6]
id: 9e0f9136bd9ef345f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/9e0f9136bd9ef345f8d69a306efd3c52
Practitioner [documentation R4 R5 R6]
id: 9e0f9136bd9ef345f8d69a306efd3c52PRACT
fullUrl: (none)
Name: Tester Testing Test
Address: European Union
email: testing@testing.com
(Use: work)
Phone: 0640403030
(Use: work)
Found a parent (PractitionerRole/organization, id: 9e0f9136bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/9e0f9136bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 16a717dc3a2a343ef8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/16a717dc3a2a343ef8d69a30addf073a
- + Alpha Pharmaceuticals GmbHIdentifier: LOC-100017452 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000500037 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: + Alpha Pharmaceuticals GmbH
Part Of
Display: + Alpha Pharmaceuticals GmbH,
Identifier: ORG-100008714 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kohlenhofstrasse 10, Innenstadt, Kaiserslautern, Rhineland-Palatinate, 67663, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Member State: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
↸arrow indicates that this PaymentNotice resource points back to the parent Task, instead of being linked forwards from it - via PaymentNotice.request
Payment Notice [documentation R4 R5 R6]
Payment Notice [documentation R4 R5 R6]
id: 28bbffe13aaa0245f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52
Identifier: (no identifier) (http://ema.europa.eu/fhir/purchaseOrder)
Notice of Payment Created: 2024-01-29 Time: 07:05:00.054Z
Status: active
Payment status: not paid
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Reporter
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Recipient
Display: EMA
↸arrow indicates that this Provenance resource points back to the parent Task, instead of being linked forwards from it
Provenance (Signature)
Provenance (Signature)
id: 0f1151bfbd9ef345f8d69a306efd3c52PROV
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/0f1151bfbd9ef345f8d69a306efd3c52PROV
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)
Provenance Type: Signature [90000000996] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-16 Time: 00:00:00+00:00
Type: Author's Signature [1.2.840.10065.1.12.1.1] (urn:iso-astm:E1762-95:2013)
When: 2024-01-16 Time: 00:00:00+00:00
By
Grouping - Confirm authority to sign: true
Type: Coauthor's Signature [1.2.840.10065.1.12.1.2] (urn:iso-astm:E1762-95:2013)
When: 2024-01-01 Time: 00:00:00+00:00
By
Grouping - Confirm authority to sign: true
When:
(Data Absent Reason: unknown)
By
Role [documentation R4 R5 R6]
id: 9e0f9136bd9ef345f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/9e0f9136bd9ef345f8d69a306efd3c52
Practitioner [documentation R4 R5 R6]
id: 9e0f9136bd9ef345f8d69a306efd3c52PRACT
fullUrl: (none)
Name: Tester Testing Test
Address: European Union
email: testing@testing.com
(Use: work)
Phone: 0640403030
(Use: work)
Found a parent (PractitionerRole/organization, id: 9e0f9136bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/9e0f9136bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 16a717dc3a2a343ef8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/16a717dc3a2a343ef8d69a30addf073a
- + Alpha Pharmaceuticals GmbHIdentifier: LOC-100017452 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000500037 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: + Alpha Pharmaceuticals GmbH
Part Of
Display: + Alpha Pharmaceuticals GmbH,
Identifier: ORG-100008714 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kohlenhofstrasse 10, Innenstadt, Kaiserslautern, Rhineland-Palatinate, 67663, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Member State: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Grouping - Confirm authority to sign: true
Product (referenced by Task) [documentation R4 R5 R6] [Resource updated] [Resource updated]
id: 600000001169
fullUrl: https://ema.europa.eu/fhir/fullUrl/MedicinalProductDefinition/600000001169
- Name: Abasaglar 100 Units/ml - Solution for injectionName type: Full name [220000000001] (https://spor.ema.europa.eu/v1/lists/220000000000) - Medicinal Product Name Part Type
Invented name part: Abasaglar
Strength name part: 100 Units/ml
Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Language: English [100000072147] (https://spor.ema.europa.eu/v1/lists/100000072057) - Language
Identifier: 600000001169 (http://ema.europa.eu/fhir/pmsId)
Identifier: EMEA/H/C/002835 (http://ema.europa.eu/fhir/mrpCpId)
Domain: Human use [100000000012] (https://spor.ema.europa.eu/v1/lists/100000000004) - Domain
Dose Form (combination of all parts): Solution for injection [100000073863] (https://spor.ema.europa.eu/v1/lists/200000000004) - Pharmaceutical Dose Form
Additional Monitoring Indicator: false (https://spor.ema.europa.eu/v1/lists/additionalMonitoringIndicator)
Paediatric Use: medicinal product not authorised for paediatric use [false] (https://spor.ema.europa.eu/v1/lists/paediatricUseIndicator)
Indication(s) text: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Operation
(failed to find ActivityDefinition reference 154799 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509229 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509228 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509233 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154810 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509231 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154809 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154796 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509238 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154808 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154807 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509234 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154805 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154800 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154803 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509239 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509241 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509226 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509242 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154804 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509232 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509230 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509237 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154802 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154797 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154801 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154806 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509227 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509235 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509236 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 154798 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Operation
(failed to find ActivityDefinition reference 7509240 in the Bundle)
Confidentiality: Confidential [200000004984] (https://spor.ema.europa.eu/v1/lists/200000004983) - Data Classification
Contact
Type: QPPV (https://spor.ema.europa.eu/v1/lists/qualifiedPersonType)
Role [documentation R4 R5 R6]
id: 11111111111111112222222233333333
fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333
Practitioner [documentation R4 R5 R6]
id: 111111111111111122222222333333330
fullUrl: (none)
Qualification: Qualified person resides and operates in the EU [200000010001] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Qualification: Qualified person is registered with EudraVigilance [200000010002] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Found a parent (PractitionerRole/organization, id: 11111111111111112222222233333333 fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 44444444444444445555555566666666
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/44444444444444445555555566666666
- Hardcoded Pharmacovigilance Organization
Name: Hardcoded Pharmacovigilance Organization
Master File
Document (failed to find DocumentReference reference 600000001169PSMF in the Bundle)
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 0a9e3fc45be0dcb8f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/0a9e3fc45be0dcb8f8d69a30f27bf067
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56132
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56132
Description: 5 cartridges
Packaging - Cartridge [100000073503] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Cartridge [100000073503] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56132MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/003 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2014-09-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56133
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56133
Description: 10 (2 x 5) pre-filled pens (multipack)
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56133MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/008 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2014-09-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56137
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56137
Description: 5 pre-filled pens
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56137MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/007 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2014-09-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56140
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56140
Description: 10 cartridges
Packaging - Cartridge [100000073503] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Cartridge [100000073503] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56140MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/009 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2015-12-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56141
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56141
Description: 5 pre-filled pens
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56141MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/012 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2015-12-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56144
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56144
Description: 10 (2 x 5) pre-filled pens (multipack)
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56144MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/013 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2015-12-09
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56145
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56145
Description: 10 (2 x 5) pre-filled pens (multipack)
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56145MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/015 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2021-06-24
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: 56146
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/56146
Description: 5 pre-filled pens
Packaging - Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled pen [100000073543] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass [200000003203] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 56146MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944/014 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Status date: 2021-06-24
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 2591033 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 2591032 in the Bundle)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 95660
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/95660
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: Insulin glargine [100000085460] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 95660 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/95660)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/substance, id: 95660 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/95660)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 0679120a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/0679120a3a2a3ab7f8d69a30addf073a
Code: Insulin glargine [100000085460] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Strength
Presentation Strength: 10.9100000000 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
Reference Substance
Strength: 100.0000000000 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 600000001169PAED
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED
- Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (Provenance/target, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6] [Resource updated]which is linked to this by resource.id
id: 3cf6719a3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/3cf6719a3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020264 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000612345 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: EMA@EMA.com
Phone: 0628744444
Address: Domenico Scarlattilaan 6, Amsterdam, Noord-Holland, 1083 HS, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: 600000001169MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: EU/1/14/944 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 2014-09-09
Date Of First Authorisation: 2014-09-08
International Birth Date: 2014-09-08
Holder
Found a parent (RegulatedAuthorization/holder, id: 56132MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56132MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56133MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56133MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56137MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56137MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56140MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56140MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56141MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56141MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56144MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56144MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56145MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56145MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 56146MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/56146MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ad26b05a3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ad26b05a3a2a3ab7f8d69a30addf073a
- Eli Lilly Nederland B.V.Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000603891 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Eli Lilly Nederland B.V.
Part Of
Display: Eli Lilly Nederland B.V.,
Identifier: ORG-100000426 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Papendorpseweg 83, Utrecht, 3528 BJ, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: Eli Lilly Nederland B.V.,
Identifier: LOC-100005434 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (Provenance/target, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6] [Resource updated]which is linked to this by resource.id
id: 3cf6719a3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/3cf6719a3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020264 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000612345 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: EMA@EMA.com
Phone: 0628744444
Address: Domenico Scarlattilaan 6, Amsterdam, Noord-Holland, 1083 HS, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Type: Centralised Procedure [100000155059] (https://spor.ema.europa.eu/v1/lists/100000154442) - EU Regulatory Authorisation/Registration Procedure
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: HTML Change [90000000997] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Old data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Lorem Medica Ipsum</strong></span></span></span><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif">Lorem medica ipsum dolor sit amet, consectetur adipiscing elit. Sed pharetra vitae justo vitae tincidunt. Proin vitae feugiat metus. Quisque ac lectus eu augue pellentesque euismod. Nullam sed neque vitae justo eleifend tempor. Duis vel elit eget turpis bibendum auctor.</span></span></span></div>
<div><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><em>Pellentesque habitant morbi tristique</em> senectus et netus et malesuada fames ac turpis egestas. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Ut vel enim et lacus suscipit aliquam. Nunc euismod ex ac urna lobortis, eget suscipit justo varius.</span></span></span></div>
<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
</div>"
New data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Curabitur eget convallis orci.</strong></span></span></span><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif">Fusce vel mi nec ligula imperdiet fermentum. Integer sodales turpis nec sapien sagittis, id euismod nisl bibendum. Sed vitae nunc quis sapien accumsan rhoncus. Nunc commodo ante vel ante fermentum, vitae fermentum justo cursus. Integer vel diam vitae risus venenatis imperdiet.</span></span></span></div>
<div><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><em>In hac habitasse platea dictumst.</em> Ut euismod nisi vitae mi volutpat, ac sodales elit dignissim. Aenean ut tellus quis elit aliquet venenatis. Sed bibendum dolor vel dui lobortis, id volutpat elit auctor. Sed vel hendrerit risus.</span></span></span></div>
<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
</div>"
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
No Organisation Reference Necessary: false
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: eae260323aaa0519f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: HTML Change [90000000997] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:44:47+00:00
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Old data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<h3 style="-webkit-text-stroke-width:0px; box-sizing:border-box; color:#232222; font-family:Verdana,sans-serif; font-size:16px; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:bold; letter-spacing:normal; line-height:1.1; margin-bottom:10.5px; margin-top:21px; orphans:2; text-align:start; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px">Present<span style="box-sizing:border-box; color:red"> </span></h3>
</div>"
New data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<h3 style="-webkit-text-stroke-width:0px; box-sizing:border-box; color:#232222; font-family:Verdana,sans-serif; font-size:16px; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:bold; letter-spacing:normal; line-height:1.1; margin-bottom:10.5px; margin-top:21px; orphans:2; text-align:start; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px">Proposed<span style="box-sizing:border-box; color:red"> </span></h3>
</div>"
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: eae260323aaa0519f8d69a306efd3c52
No Organisation Reference Necessary: false
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141ASMF Current: 1234
ASMF Proposed: 12345
↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52UPD
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: Product Change [90000000999] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Element: MedicinalProductDefinition.characteristic.type.coding[id=4886d4cc-6e42-405b-80e0-d843a08a789d]
New data:
true (https://spor.ema.europa.eu/v1/lists/gmo)
Old data:
false (https://spor.ema.europa.eu/v1/lists/gmo)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Element: MedicinalProductDefinition.characteristic[id=b38d202f-8500-4cc3-ae21-f9dbf8a1ad2c]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Element: MedicinalProductDefinition.characteristic[id=e90ea33a-c4ca-4982-b3a3-62f4b2c45a0d]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002Product (referenced by Task) [documentation R4 R5 R6] [Resource updated]
id: UAT00007007
fullUrl: https://ema.europa.eu/fhir/fullUrl/MedicinalProductDefinition/UAT00007007
- Name: Hiberix. Haemophilus Type b (Hib) vaccine
Identifier: UAT00007007 (http://ema.europa.eu/fhir/pmsId)
Identifier: IE-100001573-90000001 (http://ema.europa.eu/fhir/mpId)
Domain: Human use [100000000012] (https://spor.ema.europa.eu/v1/lists/100000000004) - Domain
Dose Form (combination of all parts): Powder and solvent for solution for injection [100000073868] (https://spor.ema.europa.eu/v1/lists/200000000006) - Combined Pharmaceutical Dose Form
Additional Monitoring Indicator: false (https://spor.ema.europa.eu/v1/lists/additionalMonitoringIndicator)
Paediatric Use: medicinal product authorised for paediatric use [true] (https://spor.ema.europa.eu/v1/lists/paediatricUseIndicator)
Indication(s) text: Hiberix is indicated for active immunisation against disease caused by Haemophilus influenzae type b in infants from the age of two months.
@id=e90ea33a-c4ca-4982-b3a3-62f4b2c45a0dCharacteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Contact
Type: QPPV (https://spor.ema.europa.eu/v1/lists/qualifiedPersonType)
Role [documentation R4 R5 R6]
id: 11111111111111112222222233333333
fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333
Practitioner [documentation R4 R5 R6]
id: 111111111111111122222222333333330
fullUrl: (none)
Qualification: Qualified person resides and operates in the EU [200000010001] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Qualification: Qualified person is registered with EudraVigilance [200000010002] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Found a parent (PractitionerRole/organization, id: 11111111111111112222222233333333 fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 44444444444444445555555566666666
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/44444444444444445555555566666666
- Hardcoded Pharmacovigilance Organization
Name: Hardcoded Pharmacovigilance Organization
Master File
Document (failed to find DocumentReference reference UAT00007007PSMF in the Bundle)
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: UAT91000000001
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/UAT91000000001
Identifier: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId)
Description: 1 vial + 1 syringe
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT91000000001MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1077/027/001/001UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 2009-11-19
Date Of First Authorisation: 2001-06-07
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: UAT91000000002MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000002MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: UAT91000000002
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/UAT91000000002
Identifier: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId)
Description: 1 vial + 1 syringe
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT91000000002MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000002MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1077/027/001/002UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 1999-11-07
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT91000000002MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000002MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 0e5a0e8b3a3a10cdf8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/0e5a0e8b3a3a10cdf8d69a30addf073a
- [ INACTIVE ] Pfizer Biotechnology Ireland Unlimited CompanyIdentifier: PARENT (https://spor.ema.europa.eu/v1/locations)
Name: [ INACTIVE ] Pfizer Biotechnology Ireland Unlimited Company
Part Of
Display: [ INACTIVE ] Pfizer Biotechnology Ireland Unlimited Company,
Identifier: ORG-100015707 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Ireland (Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: [ INACTIVE ] Pfizer Biotechnology Ireland Unlimited Company,
Identifier: PARENT (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT91000000002MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000002MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: acb69fbf3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/acb69fbf3a2a3ab7f8d69a30addf073a
- Irish Medicines BoardIdentifier: LOC-100015505 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000400065 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Irish Medicines Board
Part Of
Display: Irish Medicines Board,
Identifier: ORG-100011334 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kevin Omalley House, Earlsfort Centre, Earlsfort Terace, Dublin 2, D02 XP77, Ireland (Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: UAT91000000003
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/UAT91000000003
Identifier: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId)
Description: 1 vial + 1 ampoule
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT91000000003MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1077/027/001/003UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT91000000002MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000002MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: acb69fbf3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/acb69fbf3a2a3ab7f8d69a30addf073a
- Irish Medicines BoardIdentifier: LOC-100015505 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000400065 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Irish Medicines Board
Part Of
Display: Irish Medicines Board,
Identifier: ORG-100011334 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kevin Omalley House, Earlsfort Centre, Earlsfort Terace, Dublin 2, D02 XP77, Ireland (Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 9f19114265e3cdc7f8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) fbc1979e2365f694f8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 2ce5c0eba47f320df8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 35458a22214f0374f8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 0255a69bcaf1ae53f8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 273243cca77e8823f8d69a30f27bf067 in the Bundle)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 222a78783d24a362f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 222a78783d24a362f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 442f163854971485f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 76c9b1f44acfca97f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 70eccd3f3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/70eccd3f3a2a3ab7f8d69a30addf073a
Code: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 2e6bf5a9c2b7ee14f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 2e6bf5a9c2b7ee14f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 34c4938a99e975a6f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: fe938705ea271908f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 47b456d43a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/47b456d43a2a3ab7f8d69a30addf073a
Code: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 34c4938a99e975a6f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 2e6bf5a9c2b7ee14f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 34c4938a99e975a6f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: fe938705ea271908f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 47b456d43a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/47b456d43a2a3ab7f8d69a30addf073a
Code: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 442f163854971485f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 222a78783d24a362f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 442f163854971485f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 76c9b1f44acfca97f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 70eccd3f3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/70eccd3f3a2a3ab7f8d69a30addf073a
Code: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 76c9b1f44acfca97f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 222a78783d24a362f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 442f163854971485f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 76c9b1f44acfca97f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 70eccd3f3a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/70eccd3f3a2a3ab7f8d69a30addf073a
Code: HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) [100000144019] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: b4278eecc1833eaaf8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/b4278eecc1833eaaf8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) [100000089691] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: b4278eecc1833eaaf8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/b4278eecc1833eaaf8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: a9ff66c83a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/a9ff66c83a2a3ab7f8d69a30addf073a
Code: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) [100000089691] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: fe938705ea271908f8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 2e6bf5a9c2b7ee14f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: 34c4938a99e975a6f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Ingredient/code, id: fe938705ea271908f8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: 47b456d43a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/47b456d43a2a3ab7f8d69a30addf073a
Code: TETANUS TOXOID [100000089740] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT00007007PAED
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED
- Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ccbf48283a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ccbf48283a2a3ab7f8d69a30addf073a
- Health Products Regulatory AuthorityIdentifier: LOC-100000032 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000500021 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Health Products Regulatory Authority
Part Of
Display: Health Products Regulatory Authority,
Identifier: ORG-100003927 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, Ireland (Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT00007007MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1077/027/001UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid - Renewed/Varied [200000017708] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 2009-11-24
Date Of First Authorisation: 1999-06-10
International Birth Date: 1996-06-29
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ccbf48283a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ccbf48283a2a3ab7f8d69a30addf073a
- Health Products Regulatory AuthorityIdentifier: LOC-100000032 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000500021 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: Health Products Regulatory Authority
Part Of
Display: Health Products Regulatory Authority,
Identifier: ORG-100003927 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, Ireland (Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Type: National Procedure [100000155062] (https://spor.ema.europa.eu/v1/lists/100000154442) - EU Regulatory Authorisation/Registration Procedure
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: HTML Change [90000000997] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Old data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Lorem Medica Ipsum</strong></span></span></span><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif">Lorem medica ipsum dolor sit amet, consectetur adipiscing elit. Sed pharetra vitae justo vitae tincidunt. Proin vitae feugiat metus. Quisque ac lectus eu augue pellentesque euismod. Nullam sed neque vitae justo eleifend tempor. Duis vel elit eget turpis bibendum auctor.</span></span></span></div>
<div><br>
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<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
</div>"
New data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Curabitur eget convallis orci.</strong></span></span></span><br>
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<div><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><em>In hac habitasse platea dictumst.</em> Ut euismod nisi vitae mi volutpat, ac sodales elit dignissim. Aenean ut tellus quis elit aliquet venenatis. Sed bibendum dolor vel dui lobortis, id volutpat elit auctor. Sed vel hendrerit risus.</span></span></span></div>
<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
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Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
No Organisation Reference Necessary: false
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52UPD
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: Product Change [90000000999] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Element: MedicinalProductDefinition.characteristic.type.coding[id=4886d4cc-6e42-405b-80e0-d843a08a789d]
New data:
true (https://spor.ema.europa.eu/v1/lists/gmo)
Old data:
false (https://spor.ema.europa.eu/v1/lists/gmo)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Element: MedicinalProductDefinition.characteristic[id=b38d202f-8500-4cc3-ae21-f9dbf8a1ad2c]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Element: MedicinalProductDefinition.characteristic[id=e90ea33a-c4ca-4982-b3a3-62f4b2c45a0d]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002Product (referenced by Task) [documentation R4 R5 R6] [Resource updated]
id: UAT900000000666
fullUrl: https://ema.europa.eu/fhir/fullUrl/MedicinalProductDefinition/UAT900000000666
- Name: Abacus Control gastro-resistant tablets 66 mg
Identifier: UAT900000000666 (http://ema.europa.eu/fhir/pmsId)
Identifier: DE-100000833-00000666 (http://ema.europa.eu/fhir/mpId)
Identifier: IE/H/0655/666UAT (http://ema.europa.eu/fhir/mrpCpId)
Domain: Human use [100000000012] (https://spor.ema.europa.eu/v1/lists/100000000004) - Domain
Dose Form (combination of all parts): Gastro-resistant tablet [100000073667] (https://spor.ema.europa.eu/v1/lists/200000000004) - Pharmaceutical Dose Form
Additional Monitoring Indicator: false (https://spor.ema.europa.eu/v1/lists/additionalMonitoringIndicator)
Indication(s) text: Abacus Control gastro-resistant tablets is indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
@id=b38d202f-8500-4cc3-ae21-f9dbf8a1ad2cCharacteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Contact
Type: QPPV (https://spor.ema.europa.eu/v1/lists/qualifiedPersonType)
Role [documentation R4 R5 R6]
id: 11111111111111112222222233333333
fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333
Practitioner [documentation R4 R5 R6]
id: 111111111111111122222222333333330
fullUrl: (none)
Qualification: Qualified person resides and operates in the EU [200000010001] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Qualification: Qualified person is registered with EudraVigilance [200000010002] (https://spor.ema.europa.eu/v1/lists/200000010000) - Qualifications
Found a parent (PractitionerRole/organization, id: 11111111111111112222222233333333 fullUrl: https://ema.europa.eu/fhir/fullUrl/PractitionerRole/11111111111111112222222233333333)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 44444444444444445555555566666666
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/44444444444444445555555566666666
- Hardcoded Pharmacovigilance Organization
Name: Hardcoded Pharmacovigilance Organization
Master File
Document (failed to find DocumentReference reference UAT900000000666PSMF in the Bundle)
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/valueReference, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/subject, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
Package [documentation R4 R5 R6]which is linked to this by resource.id
id: UAT00006000666
fullUrl: https://ema.europa.eu/fhir/fullUrl/PackagedProductDefinition/UAT00006000666
Identifier: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId)
Description: 10 tablets
Packaging - Box [100000073498] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Box [100000073498] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Cardboard [200000003529] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Shelf Life: Shelf life of the medicinal product as packaged for sale [100000073403] (https://spor.ema.europa.eu/v1/lists/100000073343) - Shelf Life Type - 3 year [a] (http://unitsofmeasure.org)
Coded Unit: year [200000003434] (https://spor.ema.europa.eu/v1/lists/100000110633) - Units of Measurement
Special Precautions: Store in a refrigerator (2°C – 8°C) [100000073414] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: Store in the original package [100000073421] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: Do not freeze [100000073420] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: in order to protect from light [100000073426] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Shelf Life: Shelf life after dilution or reconstitution according to directions [100000073405] (https://spor.ema.europa.eu/v1/lists/100000073343) - Shelf Life Type - 1 hour [h] (http://unitsofmeasure.org)
Coded Unit: hour [100000110804] (https://spor.ema.europa.eu/v1/lists/100000110633) - Units of Measurement
Packaging - Pre-filled syringe [100000073544] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled syringe [100000073544] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass type I [200000003204] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Packaging (part) - Pre-filled syringe [100000073544] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Pre-filled syringe [100000073544] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass type I [200000003204] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Packaging (part) - Stopper [100000073557] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Stopper [100000073557] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Rubber [200000003226] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Amount: 1 millilitre(s) (failed to find ManufacturedItemDefinition reference (or DeviceDefinition) bbf9727b2f73cdf3f8d69a30f27bf067 in the Bundle)
Packaging - Vial [100000073563] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Vial [100000073563] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass type I [200000003204] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Shelf Life: Shelf life of the medicinal product as packaged for sale [100000073403] (https://spor.ema.europa.eu/v1/lists/100000073343) - Shelf Life Type - 3 year [a] (http://unitsofmeasure.org)
Coded Unit: year [200000003434] (https://spor.ema.europa.eu/v1/lists/100000110633) - Units of Measurement
Special Precautions: Store in a refrigerator (2°C – 8°C) [100000073414] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: Store in the original package [100000073421] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: in order to protect from light [100000073426] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Special Precautions: Do not freeze [100000073420] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Shelf Life: Shelf life after dilution or reconstitution according to directions [100000073405] (https://spor.ema.europa.eu/v1/lists/100000073343) - Shelf Life Type - 1 hour [h] (http://unitsofmeasure.org)
Coded Unit: hour [100000110804] (https://spor.ema.europa.eu/v1/lists/100000110633) - Units of Measurement
Special Precautions: This medicinal product does not require any special storage conditions [100000073424] (https://spor.ema.europa.eu/v1/lists/100000073344) - Special Precautions for Storage
Packaging (part) - Stopper [100000073557] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Stopper [100000073557] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Rubber [200000003226] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Packaging (part) - Cap [100000073502] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Cap [100000073502] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Aluminium [200000003200] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Packaging (part) - Vial [100000073563] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging, 1
Identifier: 12345678901234 (http://ema.europa.eu/fhir/dataCarrierIdentifier)
Type: Vial [100000073563] (https://spor.ema.europa.eu/v1/lists/100000073346) - Packaging
Quantity: 1
Material: Glass type I [200000003204] (https://spor.ema.europa.eu/v1/lists/200000003199) - Material
Amount: 1 unit(s) (failed to find ManufacturedItemDefinition reference (or DeviceDefinition) 6a696470feb495c6f8d69a30f27bf067 in the Bundle)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent PackagedProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT00006000666MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1410/066/666/001UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Federal Republic of Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 2022-01-01
Date Of First Authorisation: 2022-01-01
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 869e1c434882b7e3f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/869e1c434882b7e3f8d69a30addf073a
- +365 Medicines GmbHIdentifier: LOC-100054861 (https://spor.ema.europa.eu/v1/locations)
Name: +365 Medicines GmbH
Part Of
Display: +365 Medicines GmbH,
Identifier: ORG-100034581 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Sandstrasse 107-135, Mitte, Muelheim An Der Ruhr, North Rhine-Westphalia, 45473, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 6438f263946db61ff8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) bbf9727b2f73cdf3f8d69a30f27bf067 in the Bundle)
Comprised Of (failed to find DeviceDefinition reference (or ManufacturedItemDefinition) 6a696470feb495c6f8d69a30f27bf067 in the Bundle)
Ingredient - Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
[documentation R4 R5 R6]
id: 6d4f4c8340f8b59ef8d69a30f27bf067
fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/6d4f4c8340f8b59ef8d69a30f27bf067
Status: active
Role: Active [100000072072] (https://spor.ema.europa.eu/v1/lists/100000072050) - Ingredient Role
Substance: Omeprazole [100000092047] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
Found a parent (Ingredient/code, id: 6d4f4c8340f8b59ef8d69a30f27bf067 fullUrl: https://ema.europa.eu/fhir/fullUrl/Ingredient/6d4f4c8340f8b59ef8d69a30f27bf067)
which is linked to this by resource.id
Substance [documentation R4 R5 R6]which is linked to this by resource.id
id: deee7cb63a2a3ab7f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/SubstanceDefinition/deee7cb63a2a3ab7f8d69a30addf073a
Code: Omeprazole [100000092047] (https://spor.ema.europa.eu/v1/lists/substanceDefinition)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT900000000666PAED
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED
- Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Paediatric Use [220000000065] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 869e1c434882b7e3f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/869e1c434882b7e3f8d69a30addf073a
- +365 Medicines GmbHIdentifier: LOC-100054861 (https://spor.ema.europa.eu/v1/locations)
Name: +365 Medicines GmbH
Part Of
Display: +365 Medicines GmbH,
Identifier: ORG-100034581 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Sandstrasse 107-135, Mitte, Muelheim An Der Ruhr, North Rhine-Westphalia, 45473, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
↸arrow indicates that this RegulatedAuthorization resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via RegulatedAuthorization.subject
Authorisation [documentation R4 R5 R6]
Authorisation [documentation R4 R5 R6]
id: UAT900000000666MKTRA
fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA
- Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement TypeType: Marketing Authorisation [220000000061] (https://spor.ema.europa.eu/v1/lists/220000000060) - Regulatory Entitlement Type
Identifier: PA1410/066/666UAT (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [100000072099] (https://spor.ema.europa.eu/v1/lists/100000072049) - Regulatory Entitlement Status
Region: Federal Republic of Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Status date: 2022-01-01
Date Of First Authorisation: 2022-01-01
International Birth Date: 2022-01-01
Holder
Found a parent (RegulatedAuthorization/holder, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT00007007PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00007007PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000001MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000001MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/holder, id: UAT91000000003MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT91000000003MKTRA)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: ac2561a5bd8a1c88f8d69a30ff82119d
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/ac2561a5bd8a1c88f8d69a30ff82119d
- UAT ORG (ORG-200036098)Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Identifier: 123456789 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: UAT ORG (ORG-200036098)
Part Of
Display: UAT ORG (ORG-200036098),
Identifier: ORG-200036098 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: UAT-LOC11 P.O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: UAT ORG (ORG-200036098),
Identifier: LOC-200057132 (https://spor.ema.europa.eu/v1/locations)
Regulator
Found a parent (RegulatedAuthorization/regulator, id: UAT00006000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT00006000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: UAT900000000666PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/UAT900000000666PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 869e1c434882b7e3f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/869e1c434882b7e3f8d69a30addf073a
- +365 Medicines GmbHIdentifier: LOC-100054861 (https://spor.ema.europa.eu/v1/locations)
Name: +365 Medicines GmbH
Part Of
Display: +365 Medicines GmbH,
Identifier: ORG-100034581 (https://spor.ema.europa.eu/v1/organizations)
Contact
Address: Sandstrasse 107-135, Mitte, Muelheim An Der Ruhr, North Rhine-Westphalia, 45473, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Case
Type: Mutual Recognition Procedure [100000155061] (https://spor.ema.europa.eu/v1/lists/100000154442) - EU Regulatory Authorisation/Registration Procedure
Date: 2024-01-29
Concerned Member State: Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Concerned Member State: Ireland [100000000427] (https://spor.ema.europa.eu/v1/lists/100000160962) - EU Procedural Authority Role
Reference Country: European Union [100000000390] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country
Application
Type: Variation Type IB [100000155692] (https://spor.ema.europa.eu/v1/lists/100000155688) - Application Submission Type
↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: HTML Change [90000000997] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Old data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Lorem Medica Ipsum</strong></span></span></span><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif">Lorem medica ipsum dolor sit amet, consectetur adipiscing elit. Sed pharetra vitae justo vitae tincidunt. Proin vitae feugiat metus. Quisque ac lectus eu augue pellentesque euismod. Nullam sed neque vitae justo eleifend tempor. Duis vel elit eget turpis bibendum auctor.</span></span></span></div>
<div><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><em>Pellentesque habitant morbi tristique</em> senectus et netus et malesuada fames ac turpis egestas. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Ut vel enim et lacus suscipit aliquam. Nunc euismod ex ac urna lobortis, eget suscipit justo varius.</span></span></span></div>
<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
</div>"
New data: "<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div><span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><strong>Curabitur eget convallis orci.</strong></span></span></span><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif">Fusce vel mi nec ligula imperdiet fermentum. Integer sodales turpis nec sapien sagittis, id euismod nisl bibendum. Sed vitae nunc quis sapien accumsan rhoncus. Nunc commodo ante vel ante fermentum, vitae fermentum justo cursus. Integer vel diam vitae risus venenatis imperdiet.</span></span></span></div>
<div><br>
<span style="font-size:11pt"><span style="line-height:107?<span style="font-family:Calibri,sans-serif"><em>In hac habitasse platea dictumst.</em> Ut euismod nisi vitae mi volutpat, ac sodales elit dignissim. Aenean ut tellus quis elit aliquet venenatis. Sed bibendum dolor vel dui lobortis, id volutpat elit auctor. Sed vel hendrerit risus.</span></span></span></div>
<div> </div>
<div><img alt="jquery - Flot JS - first bar border is thinner than others - Stack Overflow" src="https://i.stack.imgur.com/JOiNx.png"></div>
</div>"
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
No Organisation Reference Necessary: false
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002↸arrow indicates that this Provenance resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: f73211633a28684cf8d69a306efd3c52UPD
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: Product Change [90000000999] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:42:26+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Target
Resource: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Element: MedicinalProductDefinition.characteristic.type.coding[id=4886d4cc-6e42-405b-80e0-d843a08a789d]
New data:
true (https://spor.ema.europa.eu/v1/lists/gmo)
Old data:
false (https://spor.ema.europa.eu/v1/lists/gmo)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Element: MedicinalProductDefinition.characteristic[id=b38d202f-8500-4cc3-ae21-f9dbf8a1ad2c]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Target
Resource: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Element: MedicinalProductDefinition.characteristic[id=e90ea33a-c4ca-4982-b3a3-62f4b2c45a0d]
New data:
Characteristic
Type: true (https://spor.ema.europa.eu/v1/lists/gmo)
Complies With Directive?: true
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002↸arrow indicates that this Provenance resource points back to the parent , instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: b66c57edbd9ef345f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: Organisation Change [90000000998] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-16 Time: 10:06:35+00:00
Based on: A.3 Change in name of the active substance or of an excipient
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Target
Resource: Found a parent (Provenance/target, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169MKTRA fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169MKTRA)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (RegulatedAuthorization/regulator, id: 600000001169PAED fullUrl: https://ema.europa.eu/fhir/fullUrl/RegulatedAuthorization/600000001169PAED)
which is linked to this by resource.id
Organization [documentation R4 R5 R6] [Resource updated]which is linked to this by resource.id
id: 3cf6719a3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/3cf6719a3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020264 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000612345 (http://ema.europa.eu/fhir/organizationAccountNumber)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: EMA@EMA.com
Phone: 0628744444
Address: Domenico Scarlattilaan 6, Amsterdam, Noord-Holland, 1083 HS, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Current Version of Resource
Found a parent (Provenance/valueReference, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: b66c57edbd9ef345
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/b66c57edbd9ef345
- EMA manual orgIdentifier: (no identifier)
(Data Absent Reason: unknown)
Name: EMA manual org
Contact
Address: Testing 123, Utrecht, Utrecht, 3555EM, Antarctica
Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: f73211633a28684cf8d69a306efd3c52
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Shortcut to product affected by this change: Abacus Control gastro-resistant tablets 66 mg (MedicinalProductDefinition) id: UAT900000000666Shortcut to product affected by this change: Hiberix. Haemophilus Type b (Hib) vaccine (MedicinalProductDefinition) id: UAT00007007Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56137Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56146Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56145Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56132Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56144Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 0a9e3fc45be0dcb8f8d69a30f27bf067Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141Package selected for this variation: DE-100000833-00000666-0001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT00006000666Package selected for this variation: IE-100001573-00000001-0003 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000003Package selected for this variation: IE-100001573-90000002-001 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000001Package selected for this variation: IE-100001573-00000001-0002 (http://ema.europa.eu/fhir/pcId) (PackagedProductDefinition) id: UAT91000000002↸arrow indicates that this Provenance resource points back to the parent , instead of being linked forwards from it
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance (Change) UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
id: c18026c4bd9ef345f8d69a306efd3c52
fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Provenance Type: Organisation Change [90000000998] (https://spor.ema.europa.eu/v1/lists/90000000995) - Provenance Type
Recorded: 2024-01-17 Time: 11:44:27+00:00
Based on: A.1 Change in the name and/or address of the marketing authorisation holder
Target
Resource: Found a parent (Provenance/target, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6] [Resource updated]which is linked to this by resource.id
id: a72e71d63abcfacef8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/a72e71d63abcfacef8d69a30addf073a
- 30 Churchill Place Tenant LimitedIdentifier: LOC-100068915 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000400176 (http://ema.europa.eu/fhir/organizationAccountNumber)
Identifier: 1235467 (http://ema.europa.eu/fhir/dunsNumber)
Name: 30 Churchill Place Tenant Limited
Part Of
Display: 30 Churchill Place Tenant Limited,
Identifier: ORG-100026713 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: mail@mail.com
Phone: 123456
Address: 3rd Floor, 207 Regent Street, London, W1B 3HH, United Kingdom (United Kingdom [100000000556] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Current Version of Resource
Found a parent (Provenance/valueReference, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 25528f383a3a19bcf8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/25528f383a3a19bcf8d69a30addf073a
- 0AK Healthcare GmbHIdentifier: LOC-100043615 (https://spor.ema.europa.eu/v1/locations)
Identifier: 0000609857 (http://ema.europa.eu/fhir/organizationAccountNumber)
Identifier: 123 (http://ema.europa.eu/fhir/dunsNumber)
Name: 0AK Healthcare GmbH
Part Of
Display: 0AK Healthcare GmbH,
Identifier: ORG-100026994 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: mail@mail.com
Phone: 123
Address: Bahnstrasse 51, Steinbach (Taunus), Hesse, 61449, Germany (Germany [100000000403] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Agent
Found a parent (Task/for, id: 0f1151bfbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Task/0f1151bfbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: b66c57edbd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/b66c57edbd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: eae260323aaa0519f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/eae260323aaa0519f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: c18026c4bd9ef345f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/c18026c4bd9ef345f8d69a306efd3c52)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (Provenance/who, id: f73211633a28684cf8d69a306efd3c52UPD fullUrl: https://ema.europa.eu/fhir/fullUrl/Provenance/f73211633a28684cf8d69a306efd3c52UPD)
which is linked to this by resource.id
which is linked to this by resource.id
Found a parent (PaymentNotice/reporter, id: 28bbffe13aaa0245f8d69a306efd3c52 fullUrl: https://ema.europa.eu/fhir/fullUrl/PaymentNotice/28bbffe13aaa0245f8d69a306efd3c52)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]which is linked to this by resource.id
id: 463b294c3a2a3148f8d69a30addf073a
fullUrl: https://ema.europa.eu/fhir/fullUrl/Organization/463b294c3a2a3148f8d69a30addf073a
- European Medicines AgencyIdentifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Name: European Medicines Agency
Part Of
Display: European Medicines Agency,
Identifier: ORG-100013412 (https://spor.ema.europa.eu/v1/organizations)
Contact
email: testing@test.com
Phone: 0628700909
Address: P. O. Box 71010, Amsterdam, 1008 BA, Netherlands (Netherlands [100000000478] (https://spor.ema.europa.eu/v1/lists/100000000002) - Country)
Display: European Medicines Agency,
Identifier: LOC-100020260 (https://spor.ema.europa.eu/v1/locations)
Variation Grouping Id: eae260323aaa0519f8d69a306efd3c52
Shortcut to product affected by this change: Abasaglar 100 Units/ml - Solution for injection (MedicinalProductDefinition) id: 600000001169Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56133Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56140Package selected for this variation: Packaged Product Definition (PackagedProductDefinition) id: 56141
Warning - Found 3 copies of Ingredient with substance 'HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)'
(id=222a78783d24a362f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)(id=442f163854971485f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)(id=76c9b1f44acfca97f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)' (id=222a78783d24a362f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)(id=442f163854971485f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)(id=76c9b1f44acfca97f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)' (id=222a78783d24a362f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)(id=442f163854971485f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)(id=76c9b1f44acfca97f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)' (id=222a78783d24a362f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)(id=442f163854971485f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)(id=76c9b1f44acfca97f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)' (id=222a78783d24a362f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/222a78783d24a362f8d69a30f27bf067)(id=442f163854971485f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/442f163854971485f8d69a30f27bf067)(id=76c9b1f44acfca97f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/76c9b1f44acfca97f8d69a30f27bf067)
Warning - Found 3 copies of Ingredient with substance 'TETANUS TOXOID' (id=2e6bf5a9c2b7ee14f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/2e6bf5a9c2b7ee14f8d69a30f27bf067)(id=34c4938a99e975a6f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/34c4938a99e975a6f8d69a30f27bf067)(id=fe938705ea271908f8d69a30f27bf067)(fullUrl=https://ema.europa.eu/fhir/fullUrl/Ingredient/fe938705ea271908f8d69a30f27bf067)