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...

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...

www.ema.europa.eu The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across...

www.ema.europa.eu The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.The Committee adopted by consensus...