MHRA-100490-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • nirsevimab (MEDI8897)
Invented Name
Beyfortus
PIP Number MHRA-100490-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
Route(s) of administration
Route(s) of administration:
  • PARENTERAL
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
09/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100490-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):nirsevimab (MEDI8897).pdf
Published Date 01/05/2026