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First certification of a veterinary vaccine platform technology master file

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…

Fri Nov 8, 2024 14:38
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 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 2024DraftReference Number: EMA/PRAC/457736/2024 English (EN…, PRAC statistics:...

Thu Oct 31, 2024 17:09
EMA closed 1 November

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…

Wed Oct 30, 2024 15:10
Fostering regulatory collaboration to improve access to mpox medicines

International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for…

Fri Oct 25, 2024 12:26
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 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 International non-proprietary name (INN) Concizumab...

Fri Oct 18, 2024 13:15
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)14-17 October 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 International non-proprietary name (INN) Concizumab...

Fri Oct 18, 2024 12:55

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