Advice

Marketing Authorisation Withdrawn

On 28 February 2019, the European Commission withdrew the marketing authorisation for Arzerra (ofatumumab) in the European Union (EU). 

Medicine details

Medicine name:
ofatumumab (Arzerra)
SMC ID:
1037/15
Indication:

in combination with chlorambucil or bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
Submission type
Full
Status
Withdrawn
Date advice published
11 May 2015
Additional notes

On 28 February 2019, the European Commission withdrew the marketing authorisation for Arzerra (ofatumumab) in the European Union (EU).  The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.