European Commission to lift suspension of Octapharma MA for Octagam

The European Commission has adopted the European Medicines Agency’s recommendation 2011 to lift the suspension of the marketing authorization of Octagam (human normal immunoglobulin) and Octagam 10%, from Switzerland-based Octapharma, thus allowing both products back on the European markets.

On April 14, 2011 revised on May 12, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended lifting the European Union-wide suspension of the marketing authorizations of both Octagam and Octagam 10% which has been in place since October 4, 2010. This recommendation was based on the safeguards and an action implemented by Octapharma and is subject to certain conditions.

For every batch to be released onto the market, Octapharma will carry out a thrombin generation assay to measure substances that can cause thromboembolic events. Additionally, post-marketing studies will be implemented in order to confirm the safety of the product. The company says that the long-term experience with the use of Octagam over 17 years and Octagam 10% in over two years in the EU confirms the brand characteristics in terms of quality and tolerability.