MHRA-100920-PIP01-23-M01 (update)

Key Facts

Active Substance
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
Invented Name
  • TBD
  • CAPVAXIVE®
  • CAPVAXIVE™
PIP Number MHRA-100920-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled syringe.
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of disease caused by Streptococcus pneumoniae.
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
19/12/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100920-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Pneumococcal Polysaccharide Serotype 3 ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 6A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 7F ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 19A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 22F ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 33F ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 8 ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 9N ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 10A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 11A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 12F ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 17F ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 20A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 15A ? Diphtheria CRM197 ConjugatePneumococcal Polysaccharide.pdf
Published Date 06/01/2025