EMEA-003342-PIP02-22 - paediatric investigation plan

Enpatoran

Key facts

• Active substance:
  Enpatoran
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0401/2023
• PIP number:
  EMEA-003342-PIP02-22
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0401/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for enpatoran (EMEA-003342-PIP02-22)

Adopted Reference Number: EMA/400468/2023