Human medicines European public assessment report (EPAR): Bosulif, bosutinib, Date of authorisation: 27/03/2013, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Date of authorisation: 04/06/2004, Revision: 50, Status: Authorised

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

Human medicines European public assessment report (EPAR): Praluent, alirocumab, Date of authorisation: 23/09/2015, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Harvoni, ledispavir,sofosbuvir, Date of authorisation: 17/11/2014, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Sovaldi, sofosbuvir, Date of authorisation: 16/01/2014, Revision: 29, Status: Authorised

Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 November 2025, 09:00 (CET) to 28 November 2025, 13:00 (CET)

PSUSA/00002437/202503

PSUSA/00000811/202503