MHRA-101319-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • denecimig
Invented Name
Not yet available
PIP Number MHRA-101319-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of haemophilia A
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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
28/11/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101319-PIP01-23-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):denecimig .pdf
Published Date 17/12/2025