Hepatitis B Virus
European CHMP Issues Positive Opinion for Viread(R) for the Treatment of Chronic Hepatitis B
Published in Medical Letter on the CDC and FDA, April 6th, 2008
Gilead Sciences, Inc. (Nasdaq: GILD) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on the company's application to extend the indication for Viread(R) (tenofovir disoproxil fumarate) to include the treatment of chronic hepatitis B in adults. The application, known as a Type II variation, was submitted to European regulatory authorities in October 2007.
The CHMP's positive opinion will be forwarded to the European Commission, which will amend the Marketing Authorisation for Viread in the 27 countries of the European Union to reflect the Type II variation. The European...
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