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www.ema.europa.eu EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Ojemda (tovorafenib) to treat patients aged 6 months and older with paediatric low-grade glioma (a type of non-cancerous brain tumour). Ojemda can be used when the tumour has...
www.ema.europa.eu The vacancy notice for the next EMA Executive Director has been published in the Official Journal of the European Union, marking the beginning of the recruitment process for the most senior role at the Agency. The next Executive Director will take over the position from...
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www.ema.europa.eu EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market.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side effect of levamisole EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market.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,...