CTIS newsflash - 25 March 2025
CTIS newsflash - 25 March 2025
CTIS newsflash - 25 March 2025
EMEA-002945-PIP03-23
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
Notifying a change of marketing status
EMEA-002886-PIP02-23
Human medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 14, Status: Authorised
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
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