Collection

Early access to medicines scheme (EAMS): scientific opinions

Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols.

Published 3 June 2015
Last updated 14 July 2020 + show all updates
  1. Added Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups to the list of current EAMS

  2. Remdesivir has been removed from the list of current EAMS

  3. Added the decision: Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy

  4. The scientific opinion for Nivolumab for treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal cancer after prior chemotherapy was added to Current EAMS.

  5. Added Early access to medicines scheme (EAMS) scientific opinion on Remdesivir to list

  6. Removed entry - 'Early access to medicines scheme (EAMS) scientific opinion: tafamidis for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation'

  7. The EAMS Scientific Opinion for polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant has been removed from this page due to the granting of the EU licence

  8. Added new decision - Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for adult patients.

  9. Added new EAMS scientific opinion for Avelumab in combination with axitinib for first-line treatment of advanced renal cancer.

  10. New EAMS Scientific Opinion added to the page. This EAMS is for polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant.

  11. Added a new scientific opinion for Atezolizumab

  12. New EAMS scientific opinion on Tafamidis for the treatment of transthyretin amyloidosis added to the page.

  13. Added the EAMS scientific opinion on Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

  14. Added the positive scientific opinion for Dupilumab as a treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable.

  15. Added new EAMs scientific opinion: Atezolizumab as a treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR/ALK mutations

  16. Added patisiran-LNP to treat adults with hereditary transthyretin-mediated amyloidosis.

  17. Early Access to Medicines Scientific Opinion on Volanesorsen to treat adult patients with familial chylomicronaemia syndrome

  18. Amended to add the positive scientific opinion for emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors

  19. Added Nivolumab to treat advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies to current EAMS opinions.

  20. Removed Dupilumab (for severe atopic dermatitis) from current EAMS as this product received a marketing authorisation from the European Commission.

  21. Link to the EAMS Scientific Opinion for Alectinib has been added to the page.

  22. New EAMS scientific opinion for Raxone added to the collections page.

  23. New EAMS scientific opinion for Oxervate added to the page.

  24. Added EAMS scientific opinion: Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (HCV) infection in adults

  25. EAMS for Dupilumab published

  26. SO for pembrolizumab for non-small cell lung cancer removed from current EAMS list.

  27. New EAMS positive scientific opinion

  28. Nivolumab to treat a type of cancer of the Lymph system - the Scientific Opinion has now expired due to a positive EC decision

  29. Added link to the scientific opinion: venetoclax for the treatment of chronic lymphocytic leukaemia (CLL)

  30. Added: Early access to medicines scheme (EAMS) scientific opinion: osimertinib (AZD9291) 40 and 80mg film-coated tablets

  31. New EAM issued to Novartis for sacubitril-valsartan

  32. First published.