- Leqembi recommended for treatment of early Alzheimer’s diseaseon November 14, 2024
After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation to Leqembi (lecanemab) for treating mild…
- First certification of a veterinary vaccine platform technology master fileon November 8, 2024
EMA’s Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a vaccine platform technology master file (vPTMF) which will support and accelerate…
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024on October 31, 2024
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 28-31 October […]
- EMA closed 1 Novemberon October 30, 2024
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…
- Fostering regulatory collaboration to improve access to mpox medicineson October 25, 2024
International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for…
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024on October 18, 2024
Ten new medicines recommended for approvalThe committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in…, Positive recommendations on new medicines , Alhemo […]