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Early access to medicines scheme: expired scientific opinions

Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.

From:
Medicines and Healthcare products Regulatory Agency
Published
27 July 2015
Last updated
14 November 2023 — See all updates

Documents

Expired early access to medicines scheme scientific opinions

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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.

Published 27 July 2015
Last updated 14 November 2023 + show all updates

  1. Added 'Glofitamab, as monotherapy, in the treatment of adult patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL), after two or more lines of systemic therapy' to EAMS SO.

  2. Added cipaglucosidase to the expired page for EAMS SO

  3. Added 'Risankizumab in the treatment of moderately to severely active Crohn's disease' to the expired list. Reason: Granting of marketing authorisation

  4. 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

  5. 'Efgartigimod alfa in the treatment of myasthenia gravis (gMG)' added to Expired early access to medicines scheme scientific opinions list.

  6. Added Ascimib to the expired list

  7. Voxelotor Public Assessment Report (PAR) withdrawn. Added to Expired list

  8. Added 'Avalglucosidase alfa in the treatment of late-onset Pompe disease' to the expired list.

  9. Abrocitinib in the treatment of severe atopic dermatitis, added to expired SO page

  10. 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.

  11. 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'

  12. Updated the list of expired EAMS SO

  13. Granting of marketing authorisation for Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups

  14. Added 'Avelumab in the treatment of bladder cancer' to the list of expired opinions.

  15. Added 'Nivolumab' to the Expired scientific opinions list

  16. 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

  17. Addition of Raxone due to discontinuation of EAMS programme at the request of the company

  18. Added remdesivir to the list of expired scientific opinions

  19. Added Isatuximab (for relapsed and refractory multiple myeloma) to list of expired scientific opinions.

  20. Added new entry (Tafamidis) to HTML attachment

  21. Updating due to granting of the EU licence for Polatuzumab vedotin (for non-Hodgkin Lymphoma)

  22. We have updated the Early access to medicines scheme: expired scientific opinions

  23. Added Atezolizumab (for lung cancer)

  24. Added Atezolizumab as an expired scientific opinion

  25. Added expired scientific opinion for Dupixent following it being granted for an EU license.

  26. Updated the link to the expired scientific opinion for Nivolumab (for lung cancer).

  27. Added Volanesorsen (Rare genetic lipid disorder) to the list of expired Scientific Opinions

  28. Added the SO for Atezolizumab (for lung cancer)

  29. Added Patisiran-LNP to the list of expired scientific opinions page for EAMS SO.

  30. Added Nivolumab (for gastric cancer) to expired opinions.

  31. Added emicizumab - for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors.

  32. 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.

  33. 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.

  34. 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.

  35. Added Oxervate (for moderate or severe neurotrophic keratitis) to expired EAMS as it has received an EU licence.

  36. Added Atezolizumab (for bladder cancer) to list of expired EAMS opinions

  37. Added Pembrolizumab (for lung cancer) to expired opinions.

  38. Added Venetoclax (for chronic lymphocytic leukaemia) to expired opinions.

  39. New expired opinion for Nivolumab

  40. Added expired scientific opinion for pembrolizumab lung cancer.

  41. First published.

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