Pfizer's (PFE) Prevenar 13 Get Positive Opinion from CHMP for Expanded Indication

November 16, 2012 8:00 AM EST
On 15 November 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Prevenar 13. The marketing authorization holder for this medicinal product is Pfizer Ltd (NYSE: PFE). They may request a re examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a change to an indication as follows:

"Active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age.

Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.

The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.”

Detailed conditions 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 the variation to the marketing authorisation has been granted by the European Commission.

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