www.ema.europa.eu Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage.The solidarity mechanism,...

www.ema.europa.eu The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution for injection) have been identified at wholesalers in the EU and the UK.The pens,...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended a conditional marketing authorisation in the European Union (EU) for Elrexfio (elranatamab) as a monotherapy (used on its own) for the treatment of adult patients with relapsed and refractory multiple myeloma who have...

www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.The CHMP adopted a positive opinion for Agamree* (vamorolone), for the treatment of Duchenne muscular dystrophy, a...

www.ema.europa.eu The Committee adopted by consensus a positive opinion for a marketing authorisation Nobivac LoVo L4 (a duplicate of Nobivac L4), from Intervet International B.V., a vaccine for the active immunisation of of dogs against Leptospira interrogans serogroup Canicola serovar...

www.ema.europa.eu EMA’s Management Board met on 5 October in Amsterdam.Clinical trials in the EUThe Board adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The revision focuses on the...