EMEA-000380-PIP06-19-M01 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0423/2022
• PIP number:
  EMEA-000380-PIP06-19-M01
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2022

Decision

P/0423/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (Cosentyx), (EMEA-000380-PIP06-19-M01)

AdoptedReference Number: EMA/825174/2022