EMEA-000060-PIP07-19 - paediatric investigation plan

Canakinumab

Key facts

• Invented name:
  Ilaris
• Active Substance:
  Canakinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0366/2019
• PIP number:
  EMEA-000060-PIP07-19
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of gout
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/11/2019

Decision

P/0366/2019: EMA decision of 7 November 2019 on the granting of a product specific waiver for canakinumab (Ilaris), (EMEA-000060-PIP07-19)

AdoptedReference Number: EMA/588311/2019