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European authorities give positive opinion for Fendrix vaccine.
2004 DEC 1 - (NewsRx.com & NewsRx.net) -- 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 development of novel hepatitis vaccines including vaccines for hepatitis B, combination vaccines for hepatitis A and B and pediatric combinations containing hepatitis B.
Fendrix is under investigation for the prevention of hepatitis B in patients with renal insufficiency including specific high-risk groups such as pre-hemodialysis and hemodialysis patients, from 15 years of age onwards.
Fendrix includes the GSK Bio Hepatitis B antigen and a novel proprietary GSK Bio adjuvant, AS04, which in turn contains MPL adjuvant from Corixa. Adjuvants are formulated compounds or additives, that ...
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