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GSK's H1N1 vaccine gains EU approval

GlaxoSmithKline has confirmed that it has been granted a marketing authorisation by the European Commission for its H1N1 vaccine

GlaxoSmithKline (GSK) has confirmed that it has been granted a marketing authorisation for Pandemrix, its H1N1 vaccine, from the European Commission.

Jean Stéphenne, president of GlaxoSmithKline Biologicals, said: "Following the Commission's approval we expect to commence shipments of Pandemrix to European governments from next week [w/c October 5]."

The European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and recommended approval of Pandemrix on September 25. Trials of the vaccine began in August and demonstrated that after one dose the vaccine can provide a strong immune response that exceeds the immunogenic criteria defined by international licensing authorities for a pandemic influenza vaccine.

1st October 2009

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