EMEA-000036-PIP01-07-M06

  • Email
  • Help

Overview

Product details for Prevenar 13
Invented namePrevenar 13
Active substance

13-valent pneumococcal polysaccharide conjugate vaccine: pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F; diphtheria CRM197 conjugate

Decision numberP/0161/2012
PIP numberEMEA-000036-PIP01-07-M06
Pharmaceutical form(s)Suspension for injection
Condition(s)/indication(s)

Disease caused by Streptococcus pneumoniae

Route(s) of administrationIntramuscular use
PIP applicant

Pfizer Ltd
pip_enquiries@pfizer.com
United Kingdom
Phone: +44 (0) 1304 646607
Fax: +44 (0) 1304 653601

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000036-PIP01-07-M06
Compliance check opinion date10/10/2014
Compliance check outcomePositive

Decision

Related information