MHRA-100161-PIP01-21-M01 (update)

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
Invented Name
Not available at present
PIP Number MHRA-100161-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
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
29/07/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100161-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Pneumococcal Polysaccharide Serotype 1 - Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 3 - Diphtheria CRM197 ConjugatePneumococcal Polysaccharide Serotype 4 - Diphtheria CR.pdf
Published Date 14/04/2026