EMEA-003425-PIP01-23 - paediatric investigation plan

belumosudil

Key facts

• Active Substance:
  belumosudil
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0065/2024
• PIP number:
  EMEA-003425-PIP01-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of graft versus host disease
• Route(s) of administration:
  • Oral use
  • Naso-gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/03/2024

Decision

P/0065/2024 : EMA decision of 8 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for belumosudil, (EMEA-003425-PIP01-23)

AdoptedReference Number: EMA/87429/2024