MHRA-100258-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • Clesrovimab
Invented Name
Not yet available
PIP Number MHRA-100258-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of lower respiratory tract infection 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
Yes
Compliance Check Decision Date
Compliance opinion date
22/07/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100258-PIP01-21-M03-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Clesrovimab.pdf
Published Date 04/09/2026