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
• Contact for public enquiries:

  Shire Orphan Therapies GmbH

  United States; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/11/2012

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)

AdoptedReference Number: EMA/739090/2012