EMEA-003002-PIP04-23 - paediatric investigation plan

avenciguat

Key facts

• Active substance:
  avenciguat
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMEA-003002-PIP04-23
• PIP number:
  EMEA-003002-PIP04-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate formulation
• 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:
  14/04/2025
• Compliance check done:
  Nej

Decision

EMEA-003002-PIP04-23: EMA decision of 14 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for avenciguat

Adopted Reference Number: EMADOC-1700519818-2035631