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Marketing Authorisation Withdrawn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:
idelalisib (Zydelig)
SMC ID:
1212/16
Indication:

In combination with ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia:

  • who have received at least one prior therapy, or
  • first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
Pharmaceutical company
Gilead Sciences Ltd
Submission type
Non submission
Status
Withdrawn
Date advice published
12 December 2016
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.