EMEA-000408-PIP01-08-M05 - paediatric investigation plan

icatibant acetate

Key facts

• Invented name:
  • Firazyr
  • Firazyr
• Active Substance:
  icatibant acetate
• Therapeutic area:
  Other
• Decision number:
  P/0243/2015
• PIP number:
  EMEA-000408-PIP01-08-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Shire Orphan Therapies GmbH

  Switzerland; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2015
• Compliance procedure number:
  EMEA-C-000408-PIP01-08-M05
• Compliance opinion date:
  19/08/2016
• Compliance outcome:
  Positive

Decision

P/0243/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for icatibant acetate (Firazyr), (EMEA-000408-PIP01-08-M05)

AdoptedReference Number: EMA/624869/2015