www.ema.europa.eu In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public...

www.ema.europa.eu EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during...

www.ema.europa.eu EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during...

www.ema.europa.eu Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should only be used in the event of a potentially serious problem with a centrally authorised...

www.ema.europa.eu When you smell the Glühwein on the air and the radio station plays Chris Rea’s Driving Home for Christmas you know the festive season is here and it is time to reflect on another eventful year.In 2023, optimism returned to our lives with the official end of the COVID-19...

www.ema.europa.eu Work programme and budget for 2024The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.EMA and the Heads of Medicines Agencies (HMA) plan to review and update the European Medicines Agencies...