Pfizer (PFE) Receives Positive CHMP Opinion for Change to Nimenrix Marketing Authorization

November 11, 2016 7:44 AM EST

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On 10 November 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nimenrix. The marketing authorisation holder for this medicinal product is Pfizer Limited (NYSE: PFE).

The CHMP adopted an extension to the existing indication as follows2:

"Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y".

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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