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...
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Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures – www.ema.europa.eu
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...
EMA business hours over holiday period – www.ema.europa.eu
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...
Goodbye 2023: when optimism came back – www.ema.europa.eu
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...
EMA Management Board: highlights of December 2023 meeting – www.ema.europa.eu
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...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023 – www.ema.europa.eu
www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.The committee recommended granting a conditional marketing authorisation for Casgevy* (exagamglogene autotemcel), an...