EMEA-002475-PIP02-19-M02 - paediatric investigation plan

spesolimab

Key facts

• Active substance:
  spesolimab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0049/2022
• PIP number:
  EMEA-002475-PIP02-19-M02
• Pharmaceutical form(s):
  • Solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  • Prevention of generalized pustular psoriasis
  • Treatment of generalized pustular psoriasis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/02/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002475-PIP02-19-M02
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0049/2022 : EMA decision of 18 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab, (EMEA- 002475-PIP02-19-M02)

Adopted Reference Number: EMA/97983/2022