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European Ad Comm supports label expansion for Prevenar 13

Jan. 22, 2015 11:46 AM ETPfizer Inc. (PFE) StockPFEBy: Douglas W. House, SA News Editor
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for an expanded label for Pfizer's (PFE -0.2%) Prevenar 13 to include the prevention of pneumonia in patients at least 18 years old caused by the 13 pneumococcal serotypes in the vaccine.
  • Prevenar's current indication in Europe is for the prevention of invasive pneumococcal disease in the same population.
  • A final decision from the European Commission usually takes ~60 days.

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