EMEA-000060-PIP02-08-M06 - paediatric investigation plan

Canakinumab

Key facts

• Invented name:
  • Ilaris
  • Ilaris
• Active Substance:
  Canakinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0141/2013
• PIP number:
  EMEA-000060-PIP02-08-M06
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Powder and solvent for solution for injection
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of juvenile idiopathic arthritis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/07/2013
• Compliance procedure number:
  EMEA-C-000060-PIP02-08-M06
• Compliance opinion date:
  09/10/2015
• Compliance outcome:
  Positive

Decision

P/0141/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris) (EMEA-000060-PIP02-08-M06)

AdoptedReference Number: EMA/331976/2013