List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
Human medicines European public assessment report (EPAR): Synjardy, empagliflozin,metformin, Date of authorisation: 27/05/2015, Revision: 32, Status: Authorised
Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2025
Human medicines European public assessment report (EPAR): Shingrix, herpes zoster vaccine (recombinant, adjuvanted), Date of authorisation: 21/03/2018, Revision: 14, Status: Authorised
Human medicines European public assessment report (EPAR): Descovy, emtricitabine,tenofovir alafenamide, Date of authorisation: 21/04/2016, Revision: 21, Status: Authorised
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)
Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)
Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 61, Status: Authorised
Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Authorised
Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised