EMEA-000380-PIP01-08-M04 - paediatric investigation plan

Secukinumab

Key facts

• Invented name:
  • Cosentyx
  • Cosentyx
• Active Substance:
  Secukinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0352/2017
• PIP number:
  EMEA-000380-PIP01-08-M04
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2017
• Compliance procedure number:
  EMEA-C-000380-PIP01-08-M04
• Compliance opinion date:
  20/04/2021
• Compliance outcome:
  Positive

Decision

P/0352/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (Cosentyx) (EMEA-000380-PIP01-08-M04)

AdoptedReference Number: EMA/724324/2017