EMEA-002850-PIP03-22 - paediatric investigation plan

dersimelagon

Key facts

• Active substance:
  dersimelagon
• Therapeutic area:
  Other
• Decision number:
  P/0290/2023
• PIP number:
  EMEA-002850-PIP03-22
• Pharmaceutical form(s):
  • Age appropriate oral formulation
  • Tablet
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• 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:
  04/08/2023
• Compliance check done:
  No

Decision

P/0290/2023 : EMA decision of 4 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dersimelagon (EMEA-002850-PIP03-22)

Reference Number: EMA/339220/2023