EMEA-000408-PIP02-12 - paediatric investigation plan

icatibant

Key facts

• Invented name:
  Firazyr
• Active substance:
  icatibant
• Therapeutic area:
  Other
• Decision number:
  P/0282/2012
• PIP number:
  EMEA-000408-PIP02-12
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of ACE inhibitor-induced angioedema
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/11/2012
• Compliance check done:
  Nein

Decision

P/0282/2012: EMA decision of 23 November 2012 on the granting of a product-specific waiver for icatibant (Firazyr), (EMEA-000408-PIP02-12)

Adopted Reference Number: EMA/739090/2012