Opinion/decision on a Paediatric investigation plan (PIP): RSV preF protein, decision type: , therapeutic area: , PIP number: P/0350/2022

Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Adrenal Hyperplasia, Congenital, Date of authorisation: 27/05/2021, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms, Date of authorisation: 20/04/2012, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Diacomit, stiripentol, Myoclonic Epilepsy, Juvenile, Date of authorisation: 03/01/2007, Date of refusal: 11/02/2009, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Aquipta, atogepant, Migraine Disorders, Date of authorisation: 11/08/2023, Status: Authorised

Apomorphine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000227/202211

Apomorphine : List of nationally authorised medicinal products - PSUSA/00000227/202211

Human medicines European public assessment report (EPAR): Regkirona, regdanvimab, COVID-19 virus infection, Date of authorisation: 12/11/2021, Revision: 8, Status: Authorised

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), Online, 13:00 - 14:00 Amsterdam time (CEST), from 14/07/2023 to 14/07/2023

Opinion/decision on a Paediatric investigation plan (PIP): ritlecitinib, decision type: , therapeutic area: , PIP number: P/0333/2022