EMEA-000380-PIP09-21 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0130/2022
• PIP number:
  EMEA-000380-PIP09-21
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of lichen planus (including mucosal lichen planus)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/04/2022

Decision

P/0130/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP09-21)

AdoptedReference Number: EMA/193522/2022