Results (3617)
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.
NewsHumanMedicines
Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
NewsHumanPharmacovigilanceReferrals
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
NewsHumanPharmacovigilanceReferrals
The midterm report of the European Medicines Agencies Network Strategy finds the pandemic strengthened the network and supported transformative change in the European system across key strategic areas.
NewsCorporate
The European Medicines Agency's (EMA) office is closed from Friday 22 December 2023 to Wednesday 3 January 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.
NewsCorporate
EMA's Executive Director, Emer Cooke, shares her end-of-year message and takes stock of EMA's work in 2023.
NewsCorporate
EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.
NewsCorporateData on medicines
The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.
NewsHumanVeterinaryCorporate
EMA has recommended approval of the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy (exagamglogene autotemcel) is indicated for the treatment of transfusion‑dependent beta thalassemia and severe sickle cell disease in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a...
NewsHumanMedicines
EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.
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