EMEA-000380-PIP10-23 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0201/2023
• PIP number:
  EMEA-000380-PIP10-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of polymyalgia rheumatica
• Route(s) of administration:
  All routes of administration
• 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:
  13/06/2023

Decision

P/0201/2023 : EMA decision of 13 June 2023 on the granting of a product specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP10-23)

Reference Number: EMA/241874/2023