EMEA-000380-PIP08-21 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0560/2021
• PIP number:
  EMEA-000380-PIP08-21
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of vasculitides
• 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:
  03/12/2021

Decision

P/0560/2021 : EMA decision of 31 December 2021 on the granting of a product specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP08-21)

AdoptedReference Number: EMA/649533/2021