EMEA-001886-PIP01-15-M01 - paediatric investigation plan

recombinant rusion protein linking coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)

Key facts

• Active substance:
  recombinant rusion protein linking coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0207/2017
• PIP number:
  EMEA-001886-PIP01-15-M01
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  • Treatment of Haemophilia A
  • Treatment of Haemophilia B
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2017
• Compliance check done:
  No

Decision

P/0207/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689) (E...

Adopted Reference Number: EMA/466902/2017