www.ema.europa.eu The European Medicines Agency's (EMA) office is closed on Wednesday 1 November and Thursday 2 November 2023 for All Saints’ Day and All Souls’ Day.Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781...

www.ema.europa.eu GLP-1 receptor agonists: available evidence not supporting link with thyroid cancerEMA’s safety committee (PRAC) has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1) - exenatide,...

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...