www.ema.europa.eu New safety information for Omega-3-acid ethyl estersThe PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3-acid ethyl esters. These medicines are indicated...

www.ema.europa.eu Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment. EUnetHTA 21 ceases to...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer of the bone marrow). Blenrep is given to adults who have received at least...

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...