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

Human medicines European public assessment report (EPAR): Flucelvax, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 15/11/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Wegovy, semaglutide, Date of authorisation: 06/01/2022, Revision: 17, Status: Authorised

Classification of changes: questions and answers

Changing the labelling and package leaflet (Article 61(3) notifications)

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

PCWP/HCPWP joint meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:15 (CEST) to 1 July 2026, 12:00 (CEST)

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