Hepatitis B

European authorities give positive opinion for Fendrix vaccine

Published in Blood Weekly, December 2nd, 2004

Further to the filing for regulatory approval with the European Agency for the Evaluation of Medicinal Products (EMEA) in May 2003, GlaxoSmithKline Biologicals (GSK Bio) has received a positive opinion from the Committee for Medical Products for Human Use (CHMP) of Europe dated October 21, 2004, for its adjuvanted hepatitis B vaccine, Fendrix.

The official approval is anticipated within 3 months. The EMEA and CHMP operate similarly to the U.S. Food & Drug Administration (FDA) and the FDA's advisory boards in reviewing and commenting on new products before they are approved for sale.

GSK Bio has a long history and commitment to the successful...

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Source: Blood Weekly (2004-12-02)

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