EMEA-002270-PIP04-20 - paediatric investigation plan

Marzeptacog alfa (activated)

Key facts

• Active Substance:
  Marzeptacog alfa (activated)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0482/2021
• PIP number:
  EMEA-002270-PIP04-20
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of Haemophilia B
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2021

Decision

P/0482/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for marzeptacog alfa (activated) (EMEA-002270-PIP04-20)

AdoptedReference Number: EMA/632179/2021