MHRA-100242-PIP01-21-M01 (update)

Key Facts

Active Substance
  • Respiratory syncytial virus vaccine (bivalent, recombinant)
  • Respiratory syncytial virus stabilised prefusion f subunit vaccine (RSVpreF)
Invented Name
  • Abrysvo powder and solvent for solution for injection
  • Abrysvo powder and solvent for solution for injection
PIP Number MHRA-100242-PIP01-21-M01 (update)
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 tract disease caused by respiratory syncytial virus.
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Respiratory syncytial virus vaccine (bivalent, recombinant)Respiratory syncytial virus stabilised prefusion f subunit vaccine (RSVpreF).pdf
Published Date 17/12/2025