These products were granted a positive scientific opinion (SO) by the Medicines and Healthcare products Regulatory Agency (MHRA) under the early access to medicines scheme (EAMS). The positive opinion for these products have expired following approval of marketing authorisations.
Added emicizumab - for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors.
Added Alectinib as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) to the list of expired EAMS opinions.
Added Dupilumab (for severe atopic dermatitis) to the list of expired scientific opinions for EAMS as this product received a marketing authorisation from the European Commission.
Added Glecaprevir/Pibrentasvir (for the treatment of chronic hepatitis C (HCV) infection in adults) as it has received a marketing authorisation from the European Commission.
Added Oxervate (for moderate or severe neurotrophic keratitis) to expired EAMS as it has received an EU licence.
Added Atezolizumab (for bladder cancer) to list of expired EAMS opinions
Added Pembrolizumab (for lung cancer) to expired opinions.
Added Venetoclax (for chronic lymphocytic leukaemia) to expired opinions.
New expired opinion for Nivolumab
Added expired scientific opinion for pembrolizumab lung cancer.