MHRA-100364-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
Invented Name
  • Arexvy
  • Arexvy
PIP Number MHRA-100364-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • powder and suspension for suspension 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):Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E.pdf
Published Date 24/06/2024