EMEA-000380-PIP07-20 - paediatric investigation plan

secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0111/2021
• PIP number:
  EMEA-000380-PIP07-20
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2021

Decision

P/0111/2021: EMA decision of 17 March 2021 on the granting of a product specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP07-20)

AdoptedReference Number: EMA/146109/2021