Dengvaxia : EPAR - All authorised presentations

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 11:00 (CET) to 18 November 2025, 12:00 (CET)

Human medicines European public assessment report (EPAR): Tryngolza, olezarsen, Date of authorisation: 17/09/2025, Revision: 1, Status: Authorised

Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities

Human medicines European public assessment report (EPAR): Baraclude, entecavir, Date of authorisation: 26/06/2006, Revision: 30, Status: Authorised

Classification of changes (tracked changes)

Classification of changes

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

PSUSA/00000576/202412