EMEA-002215-PIP01-17-M03

Table of contents

Key facts

Active substance
  • pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])
Therapeutic area
Vaccines
Decision number
P/0244/2019
PIP number
EMEA-002215-PIP01-17-M03
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of disease caused by Streptococcus pneumoniae
Route(s) of administration
Intramuscular use
Contact for public enquiries
Merck Sharp & Dohme (Europe), Inc.

E-mail: pip.information@merck.com
Country: Belgium
Tel. + 33 180 464 738

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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