Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Human medicines European public assessment report (EPAR): Adempas, riociguat, Date of authorisation: 27/03/2014, Revision: 18, Status: Authorised
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
Human medicines European public assessment report (EPAR): Uplizna, inebilizumab, Date of authorisation: 25/04/2022, Revision: 10, Status: Authorised
Summary of opinion: Respivac aMPV (previously Respivac TRT), 21/05/2026 Positive
Scientific and technical recommendations: Veterinary Medicines Regulation
EC request to EMA for guidance on scientific issues in relation to Articles 107(6) and 114(3) of Regulation (EU) 2019/6
Human medicines European public assessment report (EPAR): Piasky, crovalimab, Date of authorisation: 22/08/2024, Revision: 4, Status: Authorised
Human medicines European public assessment report (EPAR): Yttriga, yttrium [90Y] chloride, Date of authorisation: 19/01/2006, Revision: 11, Status: Authorised
Human medicines European public assessment report (EPAR): Yuvanci, macitentan,tadalafil, Date of authorisation: 27/09/2024, Revision: 2, Status: Authorised