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Marketing Authorisation Withdrawn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:
626/10
Indication:

Treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.

Pharmaceutical company
GlaxoSmithKline UK Ltd
Submission type
Full
Status
Withdrawn
Date advice published
09 August 2010
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.