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Last updated 9 days ago
EMA encourages companies to submit type I variations for 2024 by end November 2024
9 days ago
EMA is advising marketing authorisation holders to submit type IA and type...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
9 days ago
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight...
EMA encourages companies to submit type I variations for 2024 by end November 2024
9 days ago
EMA is advising marketing authorisation holders to submit type IA and type...
Leqembi recommended for treatment of early Alzheimer’s disease
10 days ago
After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended...
First certification of a veterinary vaccine platform technology master file
16 days ago
EMA's Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024
24 days ago
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad...
EMA closed 1 November
25 days ago
Outside of working hours and on public holidays, it is possible to...
Fostering regulatory collaboration to improve access to mpox medicines
about 1 month ago
International regulators have published a report highlighting their considerations on the development...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024
about 1 month ago
Ten new medicines recommended for approvalThe committee recommended granting a marketing authorisation...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)14-17 October 2024
about 1 month ago
Ten new medicines recommended for approvalThe committee recommended granting a marketing authorisation...
Translarna: EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine
about 1 month ago
Following a re-examination of available data, EMA’s human medicines committee (CHMP) has...
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 October 2024
about 1 month ago
CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive...