Extensions of marketing authorisations: questions and answers
Submitted by Anonymous (not verified) on 15 December 2025 - 11:45
Extensions of marketing authorisations: questions and answers
Human medicines European public assessment report (EPAR): Repatha, evolocumab, Date of authorisation: 17/07/2015, Revision: 27, Status: Authorised
Submitted by Anonymous (not verified) on 15 December 2025 - 11:40
Human medicines European public assessment report (EPAR): Repatha, evolocumab, Date of authorisation: 17/07/2015, Revision: 27, Status: Authorised
Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Date of authorisation: 07/01/2014, Revision: 28, Status: Authorised
Submitted by Anonymous (not verified) on 15 December 2025 - 11:36
Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Date of authorisation: 07/01/2014, Revision: 28, Status: Authorised
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 15 December 2025 - 11:05
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 15 December 2025 - 11:05
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group
Submitted by Anonymous (not verified) on 15 December 2025 - 10:44
Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
Submitted by Anonymous (not verified) on 15 December 2025 - 10:41
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 15 December 2025 - 9:50
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 15 December 2025 - 9:50
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Pre-authorisation guidance
Submitted by Anonymous (not verified) on 15 December 2025 - 9:45
Pre-authorisation guidance