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
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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])
InputType: 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)
InputType: Regulatory Activity subject to a Worksharing Agreement [(100000155556)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Value: true
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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).
InputType: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: n.a.
InputType: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
InputType: conditionsSet [(100000002345-temp-conditionsSet)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
InputType: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
InputType: sharing [(100000002345-temp-sharing)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Requested byOrganization 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
ByRole 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
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)
HolderOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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
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)
AgentOrganization 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).