Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 42, Status: Authorised

Non-clinical requirements for severely debilitating or life-threatening diseases

Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases

Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Date of authorisation: 13/11/2013, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Mayzent, siponimod, Date of authorisation: 13/01/2020, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Jascayd, nerandomilast, Date of authorisation: 15/07/2026, Status: Authorised

List of centrally authorised products with safety-related changes to the product information

Human medicines European public assessment report (EPAR): Leflunomide ratiopharm, leflunomide, Date of authorisation: 28/11/2010, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): PecFent, fentanyl, Date of authorisation: 31/08/2010, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 29, Status: Authorised