Summary of opinion: Koselugo, 13/11/2025 Positive

First gene therapy to treat rare disease Wiskott-Aldrich syndrome

Human medicines European public assessment report (EPAR): Juluca, dolutegravir,rilpivirine, Date of authorisation: 16/05/2018, Revision: 16, Status: Authorised

European Medicines Agency and Transcelerate bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 November 2025

Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, Date of authorisation: 16/01/2014, Revision: 37, Status: Authorised

Bronchitol

Medicine shortage communication (MSC) : Bronchitol, 40 mg inhalation powder, hard capsules: ongoing shortage

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime,avibactam, Date of authorisation: 23/06/2016, Revision: 20, Status: Authorised

Minutes of the CVMP meeting 7-9 October 2025

Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species - Scientific guideline