Extensions of marketing authorisations: questions and answers

Pre-authorisation guidance

Human medicines European public assessment report (EPAR): Filsuvez, birch bark extract, Date of authorisation: 21/06/2022, Revision: 6, Status: Authorised

Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2026 to 8 October 2026

Agenda of the CVMP meeting 6-8 October 2026

Human medicines European public assessment report (EPAR): Byooviz, ranibizumab, Date of authorisation: 18/08/2021, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Ertapenem SUN, ertapenem, Date of authorisation: 15/07/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan,hydrochlorothiazide, Date of authorisation: 19/04/2002, Revision: 41, Status: Withdrawn

Human medicines European public assessment report (EPAR): PritorPlus, telmisartan,hydrochlorothiazide, Date of authorisation: 22/04/2002, Revision: 39, Status: Withdrawn

Human medicines European public assessment report (EPAR): Aumseqa, Aumolertinib, Date of authorisation: 12/02/2026, Status: Revoked