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): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 59, Status: Authorised

Human medicines European public assessment report (EPAR): Descovy, emtricitabine,tenofovir alafenamide, Date of authorisation: 21/04/2016, Revision: 21, Status: Authorised

EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 November 2025, 13:30 (CET) to 14 November 2025, 17:30 (CET)

Medicines for human use under evaluation

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