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www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Emepax (maropitant), indicated for the prevention of nausea induced by chemotherapy, for vomiting induced by motion sickness, prevention and for...
www.ema.europa.eu EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections...
www.ema.europa.eu PRAC recommends withdrawal of marketing authorisations for levamisole medicines Leukoencephalopathy confirmed as a serious side effect of levamisole EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market. This...
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 Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2026 meeting. The committee recommended granting a marketing authorisation for Fylrevy (estetrol), a hormone replacement therapy for...
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...