Approval of Dedicated Step for Specific Prion Removal and Second Manufacturing Site for octaplas® Through a Mutual Recognition Procedure in Europe
Octapharma AG, Lachen, Switzerland In order to further enhance the safety of octaplas® against the theoretical risk of transmitting the prion disease called variant Creutzfeldt-Jakob disease (vCJD), a chromatographic step to...
Octapharma Reports octagam® 5% and octagam® 10% Global Sales Totaled 1.7 Million Grams Through October With No Thromboembolic Events
An Estimated 60,000 Patient Treatments Without Thromboembolic Events
Wolfgang Marguerre has been honored with the Grand Decoration of Honor in Gold (Grosses Goldenes Ehrenzeichen) for Services to the Republic of Austria. Mr Wolfgang Marguerre was selected for this illustrious award by Federal...
FDA Approves U.S. Market Return for octagam® Following Octapharma’s Implementation of Enhanced Safety Measures
Product Expected to Be Available for Distribution in a Few Weeks HOBOKEN, N.J. (November 4, 2011) – The U.S. Food and Drug Administration (FDA) yesterday cleared the way for the U.S. market return of octagam® [Immune...
HOBOKEN, N.J. and LACHEN, Switzerland (September 26, 2011) - Octapharma, one of the largest human protein products manufacturers in the world, has launched an international multi-center clinical study to investigate the efficacy...
Octapharma is pleased to announce that the Therapeutic Goods Administration in Australia has, on 4 August 2011, approved octagam® (normal immunoglobulin) for resupply in Australia
This is the result of excellent work by various departments within the company. We were able to identify and conclusively show FXIa to be the root cause of the unexpected increase in the occurrence of thromboembolic events...
European Commission adopts European Medicines Agency's (EMA) recommendation to lift the suspension of the marketing authorization of octagam® and octagam®10%.
On 30 May 2011 The European Commission adopted the EMA's recommendation of 14 April 2011 revised on May 12, 2011 to lift the suspension of the marketing authorization of octagam® and octagam®10%, thus allowing both products back...