EMEA-002996-PIP01-21
Submitted by Anonymous (not verified) on 28 October 2025 - 15:36
EMEA-002996-PIP01-21
Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Oncology, PIP number: P/0271/2021
Submitted by Anonymous (not verified) on 28 October 2025 - 15:35
Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Oncology, PIP number: P/0271/2021
Human medicines European public assessment report (EPAR): Votrient, pazopanib, Date of authorisation: 14/06/2010, Revision: 32, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 15:18
Human medicines European public assessment report (EPAR): Votrient, pazopanib, Date of authorisation: 14/06/2010, Revision: 32, Status: Authorised
Advanced therapy classification
Submitted by Anonymous (not verified) on 28 October 2025 - 15:02
Advanced therapy classification
Article 57 product data
Submitted by Anonymous (not verified) on 28 October 2025 - 14:25
Article 57 product data
Agenda - ACT EU multi-stakeholder platform annual meeting - October 2025
Submitted by Anonymous (not verified) on 28 October 2025 - 13:45
Agenda - ACT EU multi-stakeholder platform annual meeting - October 2025
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 28 October 2025 - 13:30
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 28 October 2025 - 13:29
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Template for sharing EMA documents by Industry to support reliance
Submitted by Anonymous (not verified) on 28 October 2025 - 13:29
Template for sharing EMA documents by Industry to support reliance
Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 24, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 13:09
Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 24, Status: Authorised