Human medicines European public assessment report (EPAR): Reagila, cariprazine, Date of authorisation: 13/07/2017, Revision: 11, 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

Human medicines European public assessment report (EPAR): Omlyclo, omalizumab, Date of authorisation: 16/05/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, Date of authorisation: 12/02/2025, Revision: 2, Status: Authorised