EMEA-000380-PIP11-23 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0282/2023
• PIP number:
  EMEA-000380-PIP11-23
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of rotator cuff tendinopathy
• 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:
  14/07/2023

Decision

P/0282/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for secukinumab (Cosentyx),(EMEA-000380-PIP11-23)

Reference Number: EMA/287965/2023