EMEA-001065-PIP01-10 - paediatric investigation plan

Bivalirudin

Key facts

• Invented name:
  • Angiox
  • Angiox
• Active substance:
  Bivalirudin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0110/2012
• PIP number:
  EMEA-001065-PIP01-10
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of atherosclerosis
  • Treatment of thrombosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  18/06/2012
• Compliance check done:
  No

Decision

P/110/2012: EMA decision of 18 June 2012 on the refusal of a paediatric investigation plan and on the granting of a waiver for bivalirudin (Angiox), (EMEA-001065-PIP01-10)

Adopted Reference Number: EMA/332323/2012