Article 57 product data
Article 57 product data
Article 57 product data
Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 27, Status: Authorised
Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 26, Status: Authorised
EMA/PE/0000232896
EMEA-000976-PIP01-10
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0131/2022
Human medicines European public assessment report (EPAR): Celsentri, maraviroc, Date of authorisation: 18/09/2007, Revision: 32, Status: Authorised
Human medicines European public assessment report (EPAR): Hetronifly, serplulimab, Date of authorisation: 03/02/2025, Revision: 4, Status: Authorised
Agenda of the CVMP meeting 13-15 January 2026
Human medicines European public assessment report (EPAR): Latuda, lurasidone, Date of authorisation: 21/03/2014, Revision: 29, Status: Authorised