Results (3623)
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.
EMA's Executive Director, Emer Cooke, shares her end-of-year message and takes stock of EMA's work in 2023.
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.
The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.
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...
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.
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Arpraziquantel used to treat schistosomiasis in young children aged 3 months to 6 years.
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
EMA’s human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.
The first version of the Union list of critical medicines contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU / EEA, for which continuity of supply is a priority and shortages should be avoided.