www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union for Kygevvi (doxecitine and doxribtimine) in patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) whose disease started at or before 12 years of age. TK2d is a rare,...

www.ema.europa.eu EMA has recommended extending the therapeutic indication of Zynyz (retifanlimab) to include treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. It is used in combination with...

www.ema.europa.eu The main role of the CAT is to evaluate applications for ATMPs submitted to EMA and draft an opinion, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine. CAT is also responsible for...

www.ema.europa.eu The HMPC is the committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market. HMPC prepares EMA’s opinions on herbal substances and preparations, along with...