Ecallantide - paediatric investigation plan

Ecallantide (recombiant inhibitor of human plasma kallikrein)

Key facts

• Active substance:
  Ecallantide (recombiant inhibitor of human plasma kallikrein)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/5/2011
• PIP number:
  Ecallantide
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2011
• Compliance check done:
  No

Decision

P/5/2011: EMA decision of 3 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ecallantide (Recombinant Inhibitor of Human Plasma Kallikrein), (EMEA-000688-PIP01-09-M01)

Adopted Reference Number: EMA/683299/2010