Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 27, Status: Authorised

Business hours and holidays

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 13, Status: Authorised

Highlight report - 14th meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

IRIS guide to registration and RPIs

ICH E6 Good clinical practice - Scientific guideline

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Trepulmix, treprostinil, Date of authorisation: 03/04/2020, Revision: 8, Status: Authorised

Paediatric-use marketing authorisations

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 28, Status: Authorised