MHRA-100347-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
Invented Name
Not available at present
PIP Number MHRA-100347-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of lower respiratory track disease caused by RSV via maternal immunisation.
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316).pdf
Published Date 02/11/2022