show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/4321/WS2025 (Hyrilox) (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Identifier: EMEA/H/C/8765/WS2025 (Hefa) (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Status: requested
Intent: order
Date: Next Production Run/Next Printing - false
Task id=variation-1 fullUrl=(none)
Code: B.I.a.2.z - QUALITY CHANGES - ACTIVE SUBSTANCE - Manufacture - Changes in the manufacturing process of the active substance - Other changes [(B.I.a.2.z)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IB [(typeIB)] (https://spor.ema.europa.eu/v1/lists/100000155688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IB [(typeIBapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IBunforeseen [(typeIBunapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeIIapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-1])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-2])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-3])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-4])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-5])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-6])
Focus: Hyrilox (MedicinalProductDefinition[id=variationProduct-1-1-7])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-8])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-9])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-10])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-11])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-12])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-13])
Focus: Hefa (MedicinalProductDefinition[id=variationProduct-1-1-14])
Input
Type: Grouping details [(grouping-code-tbc)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Single Regulatory Activity [(100000155554)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Input
Type: Regulatory Activity subject to a Worksharing Agreement [(100000155556)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Value: true
Input
Type: Change concern [(change-concern)] (https://spor.ema.europa.eu/v1/lists/example/variation-parameter-tbc)
Value: id=(none) fullUrl=(none)Quality [(Quality)] (https://spor.ema.europa.eu/v1/lists/example/change-concern-type-tbc)
Input
Type: Domain [(100000000777)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Scope [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Description of the changes:Applicant Ltd proposes to extend the(Annex B to cover letter - EMA communication).
Input
Type: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: n.a.
Input
Type: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: conditionsSet [(100000002345-temp-conditionsSet)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: sharing [(100000002345-temp-sharing)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
Applicant Ltd
Requested by
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent Task rather then being linked forwards from it
Provenance (Signature) id=signature-id fullUrl=(none)
Type: Author's Signature [(1.2.840.10065.1.12.1.1)] (urn:iso-astm:E1762-95:2013)
When: 2021-01-22
By
Role id=signature-person-id fullUrl=(none) - id=(none) fullUrl=(none)Senior Regulatory Affairs Manager [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Miss My First Name
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2021-01-22
Target
Resource: Task[id=task-application]
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)
Product id=variationProduct-1-1-1 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Extended Data Exclusivity/Marked Protection [(220000000077TODO-)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Status: Applied [(applied)] (https://spor.ema.europa.eu/v1/lists/todoAuthorisationStatus)
Holder
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-1-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-2 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-2-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-3 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-3-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/003 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-4 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-4-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/004 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-5 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-5-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/005 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-6 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-6-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/006 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-7 fullUrl=(none)
Name: Hyrilox
Invented name part: Hyrilox
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-7-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1286/007 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-8 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-8-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-9 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-9-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-10 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-10-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/003 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-11 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-11-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/004 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-12 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-12-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/005 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-13 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled pen
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled pen [(100000074039)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-13-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/006 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-14 fullUrl=(none)
Name: Hefa
Invented name part: Hefa
Pharmaceutical dose form name part: Solution for injection in pre-filled syringe
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Solution for injection in pre-filled syringe [(100000074047)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-14-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/18/1287/007 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Applicant
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2021-01-22
Based on: B.I.a.2.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-7]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-8]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-9]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-10]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-11]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-12]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-13]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-14]
Old data: "Please refer to Annex 2 to eAF - Present/proposed table"
New data: "Please refer to Annex 2 to eAF - Present/proposed table"
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Name: Applicants Representative AG
email: my.first.name.@applicant.com
Phone: +49 1234 464 2044
Address:
Industriestrasse 25
Holzkirchen
83607
Germany (Germany [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).
Warning - Found 14 copies of Ingredient ADALIMUMAB(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1)(id=Ingredient-p4-1)(id=Ingredient-p5-1)(id=Ingredient-p6-1)(id=Ingredient-p7-1)(id=Ingredient-p8-1)(id=Ingredient-p9-1)(id=Ingredient-p10-1)(id=Ingredient-p11-1)(id=Ingredient-p12-1)(id=Ingredient-p13-1)(id=Ingredient-p14-1).