| GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix |
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18/02/2012 04:06 (102 Day 10:27 minutes ago) | |||||
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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.
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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