Posted by Michael Wonder on 19 Jun 2018
Octapharma announces approval of new Nuwiq product strengths in Europe, increasing dosing flexibility for patients with haemophilia A
18 June 2018 - Octapharma announced today that the EMA has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq.
New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, 500, 1000 and 2000 IU.
The new Nuwiq vial strengths have been available in the US since September last year, following approval by the FDA. Nuwiq is indicated in adults and children of all ages for on-demand treatment and prophylaxis, including during surgery, to prevent and control bleeding episodes in patients with haemophilia A.
