EMEA-000380-PIP02-09-M04 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  • Cosentyx
  • Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0372/2018
• PIP number:
  EMEA-000380-PIP02-09-M04
• Pharmaceutical form(s):
  • Powder for solution for injection or infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/12/2018
• Compliance procedure number:
  EMEA-C-000380-PIP02-09-M04
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0372/2018: EMA decision Of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (Cosentyx), (EMEA-000380-PIP02-09-M04)

AdoptedReference Number: EMA/710588/2018