Post-authorisation safety studies (PASS)

Extensions of marketing authorisations: questions and answers

Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 31, Status: Authorised

Worksharing: questions and answers

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

Type-IB variations: questions and answers

Type-II variations: questions and answers

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Date of authorisation: 04/12/2016, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Date of authorisation: 24/04/2017, Revision: 18, Status: Withdrawn