EMEA-001174-PIP02-12-M02 - paediatric investigation plan

Turoctocog alfa pegol

Key facts

• Active Substance:
  Turoctocog alfa pegol
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0142/2017
• PIP number:
  EMEA-001174-PIP02-12-M02
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary factor VIII deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/06/2017
• Compliance procedure number:
  EMEA-C-001174-PIP02-12-M02
• Compliance opinion date:
  23/07/2021
• Compliance outcome:
  Positive

Decision

P/0142/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alfa pegol (EMEA-001174-PIP02-12-M02)

AdoptedReference Number: EMA/312705/2017