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Decision: Early access to medicines scheme: expired scientific opinions

Medicines Healthcare Products Regulatory Agency

November 27
11:50 2020

Details

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 27 November 2020 +show all updates
  1. Added 'Nivolumab' to the Expired scientific opinions list

  2. 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

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

  4. Added remdesivir to the list of expired scientific opinions

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

  6. Added new entry (Tafamidis) to HTML attachment

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

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

  9. Added Atezolizumab (for lung cancer)

  10. Added Atezolizumab as an expired scientific opinion

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

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

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

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

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

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

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

  18. 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.

  19. 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.

  20. 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.

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