GovWire

Decision: Early access to medicines scheme: expired scientific opinions

Medicines Healthcare Products Regulatory Agency

October 25
08:12 2022

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 25 October 2022 +show all updates
  1. Voxelotor Public Assessment Report (PAR) withdrawn. Added to Expired list

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

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

  4. 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.

  5. 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'

  6. Updated the list of expired EAMS SO

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

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

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

  10. 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

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

  12. Added remdesivir to the list of expired scientific opinions

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

  14. Added new entry (Tafamidis) to HTML attachment

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

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

  17. Added Atezolizumab (for lung cancer)

  18. Added Atezolizumab as an expired scientific opinion

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

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