New treatment for Niemann-Pick type C disease

Summary of opinion: Invokana, 24/07/2025 Positive

Referral: Tecovirimat SIGA, tecovirimat Article 20 procedures Procedure started

Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted

Human medicines European public assessment report (EPAR): Kisunla, donanemab, Status: Opinion

Orphan designation: Elesclomol-copper Treatment of Menkes disease, 22/06/2025 Positive

Orphan designation: zanidatamab Treatment of biliary tract cancer, 27/06/2025 Positive

Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol,glycopyrronium bromide, Date of authorisation: 18/09/2013, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Volibris, ambrisentan, Date of authorisation: 20/04/2008, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 30, Status: Authorised