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 has expired following either the approval of marketing authorisation or withdrawal from the scheme.
Added 'Risankizumab in the treatment of moderately to severely active Crohn's disease' to the expired list. Reason: Granting of marketing authorisation
Added 'Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)' to Expired SO EAMS
'Efgartigimod alfa in the treatment of myasthenia gravis (gMG)' added to Expired early access to medicines scheme scientific opinions list.
Added Ascimib to the expired list
Voxelotor Public Assessment Report (PAR) withdrawn. Added to Expired list
Added 'Avalglucosidase alfa in the treatment of late-onset Pompe disease' to the expired list.
Abrocitinib in the treatment of severe atopic dermatitis, added to expired SO page
Addition of nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2 negative (or undetermined) advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma.
Added new entry - 'Tepotinib in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations'
Updated the list of expired EAMS SO
Granting of marketing authorisation for Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups
Added 'Avelumab in the treatment of bladder cancer' to the list of expired opinions.
Added 'Nivolumab' to the Expired scientific opinions list
Addition of expired early access to medicine scientific opinion due to granting of marketing authorisation for Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy
Addition of Raxone due to discontinuation of EAMS programme at the request of the company
Added remdesivir to the list of expired scientific opinions
Added Isatuximab (for relapsed and refractory multiple myeloma) to list of expired scientific opinions.
Added new entry (Tafamidis) to HTML attachment