EMEA-000380-PIP05-18 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0144/2019
• PIP number:
  EMEA-000380-PIP05-18
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of hidradenitis suppurativa
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/04/2019

Decision

P/0144/2019: EMA decision of 17 April 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for secukinumab (Cosentyx), (EMEA-000380-PIP05-18)

AdoptedReference Number: EMA/215225/2019