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Marketing Authorisation Withdrawn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:
1237/17
Indication:

Treatment of adult patients with relapsed CLL in combination with fludarabine and cyclosphosphamide.

Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
Submission type
Non submission
Status
Withdrawn
Date advice published
10 April 2017
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.