Questions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation

Draft proposal for an addendum, on transparency, to the 'functional specifications for the European Union (EU) portal and EU database to be audited'

Human medicines European public assessment report (EPAR): Piqray, alpelisib, Breast Neoplasms, Date of authorisation: 27/07/2020, Revision: 10, Status: Authorised

Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry, from 07/12/2023 to 07/12/2023

Sixth Nitrosamine Implementation Oversight Group (NIOG) , from 07/12/2023 to 07/12/2023

Twelfth Nitrosamine Implementation Oversight Group (NIOG) meeting, from 06/12/2023 to 06/12/2023

Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate, decision type: , therapeutic area: , PIP number: P/0507/2022

Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, Date of authorisation: 18/10/2013, Revision: 15, Status: Authorised

Gemcitabine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001519/202301

Gemcitabine : List of nationally authorised medicinal products - PSUSA/00001519/202301