EMEA-003108-PIP01-21 - paediatric investigation plan

cenerimod

Key facts

• Active substance:
  cenerimod
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0433/2022
• PIP number:
  EMEA-003108-PIP01-21
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0433/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cenerimod (EMEA-003108-PIP01-21)

Adopted Reference Number: EMA/808582/2022