EMEA-002285-PIP02-19-M02 - paediatric investigation plan

marstacimab

Key facts

• Active substance:
  marstacimab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0443/2022
• PIP number:
  EMEA-002285-PIP02-19-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0443/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for marstacimab (EMEA- 002285-PIP02-19-M02)

Adopted Reference Number: EMA/823989/2022