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Wednesday, May 30, 2012
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GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix

18/02/2012 04:06 (102 Day 10:27 minutes ago)

The FINANCIAL -- GlaxoSmithKline announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for Nimenrix for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

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According to GlaxoSmithKline, a CHMP positive opinion is one of the final steps before regulatory approval. As part of its assessment, CHMP reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide.

 

 

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