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

Pharmaceutical industry

Newsletters

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin,linagliptin, Date of authorisation: 11/11/2016, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Increlex, mecasermin, Date of authorisation: 02/08/2007, Revision: 29, Status: Authorised

Classification of changes: questions and answers

Quarterly System Demo - Q1 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2026, 09:00 (CET) to 26 March 2026, 12:45 (CET)

Timetable: Initial (full) marketing authorisation application assessment

Orphan designation: N-[[(2S)-4-[(4-Methyl-1H-imidazol-5-yl)methyl]-3-oxo-2-(phenylmethyl)-1-piperazinyl]carbonyl]-L-leucine trihydrate Treatment of cutaneous T-cell lymphoma, 09/12/2025 Positive