Publication #8060

Reference
Drug alert 06/2024
Name
Drug alert class 2 – 06 2024 – Class 2 medicines recall – action within 48 hours – Novartis Pharmaceuticals UK Ltd – Adakveo 10mg/ml concentrate for solution for infusion
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion, batch number SJFN5, due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. This is because the Phase III study (STAND) of Adakveo in sickle cell disease patients with vaso-occlusive crises did not confirm its clinical benefit. As a consequence, the conditional marketing authorisation in the UK is being revoked.

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-02-21 09:52:00


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