MHRA-100239-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
Invented Name
Not yet available
PIP Number MHRA-100239-PIP01-21-M02 (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
17/12/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100239-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Multivalent pneumococcal polysaccharide conjugate to carrier protein.pdf
Published Date 11/02/2025