MHRA-100372-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • concizumab
Invented Name
  • Alhemo
  • Alhemo
PIP Number MHRA-100372-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
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
03/06/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100372-PIP01-21-M01-C1

Decision Document

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