Medicine recalls
|
| |
| The United Kingdom: Class 2 Medicines Recall: Novartis Pharmaceuticals UK Limited, Adakveo 10 mg/ml concentrate for solution for infusion |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion (crizanlizumab) (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 United Kingdom is being revoked.
Clinicians and prescribers who initiated patients on Adakveo 10 mg/ml concentrate for solution for infusion should inform patients of the licence revocation and discuss alternative treatment options with them. No new patients should be started on Adakveo in the United Kingdom.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-limited-adakveo-10-mg-slash-ml-concentrate-for-solution-for-infusion-el-24-a-slash-06
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Feb 22, 2024
Issued at HKT 14:30
|
| |
