Class 2 recall- Adakveo 10mg/ml

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.

MHRA drug alert date:21/02/24

MHRA drug alert link:https://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?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5161cd08-b491-4965-a94e-03f1b56d8e4e&utm_content=immediately

Further Information

For medical information enquiries please contact Novartis Pharmaceuticals UK Limited at: https://www.novartis.com/uk-en/contact/contact-us, by email: medinfo.uk@novartis.com or via telephone: +44 1276 698370.

For stock control enquiries please contact: commercial.team@novartis.com

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.