www.ema.europa.eu Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for the treatment of...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.The vaccine — known as Spikevax XBB.1.5 — is to be used for preventing COVID-19 in adults and children from 6 months of age.In line with...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EC) No 726/2004, the Committee adopted by consensus a positive opinion for a marketing authorisation application for Oxmax (hemoglobin betafumaril (bovine)), from New Alpha Innovation Biopharmaceutical Ireland...

www.ema.europa.eu PRAC recommends new measures to avoid topiramate exposure in pregnancyEMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental...

www.ema.europa.eu Further restrictions on use; pregnancy prevention programme to be put in placeEMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of...