EMEA-000060-PIP04-14-M01 - paediatric investigation plan

Canakinumab

Key facts

• Invented name:
  • Ilaris
  • Ilaris
• Active Substance:
  Canakinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0057/2015
• PIP number:
  EMEA-000060-PIP04-14-M01
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection
  • Powder and solvent for solution for injection
• Condition(s) / indication(s):
  • Treatment of hyperimmunoglobulin D syndrome
  • Treatment of familial Mediterranean fever
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2015
• Compliance procedure number:
  EMEA-C-000060-PIP04-14-M01
• Compliance opinion date:
  26/02/2016
• Compliance outcome:
  Positive

Decision

P/0238/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris), (EMEA-000060-PIP04-14-M01)

AdoptedReference Number: EMA/617358/2015