MHRA-100406-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • Marstacimab
Invented Name
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
PIP Number MHRA-100406-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
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 Check Procedure Number
Compliance procedure number
MHRA-100406-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MARSTACIMAB.pdf
Published Date 04/03/2026