EMA/PE/0000183673 - paediatric investigation plan

naronapride (dihydrochloride trihydrate)

Key facts

• Active substance:
  naronapride (dihydrochloride trihydrate)
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  EMA/PE/0000183673
• PIP number:
  EMA/PE/0000183673
• Pharmaceutical form(s):
  • Age-appropriate oral formulation
  • Tablet
• Condition(s) / indication(s):
  Treatment of gastroparesis
• 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:
  11/07/2025
• Compliance check done:
  Não

Decision

EMA/PE/0000183673: EMA decision of 11 July 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for naronapride (dihydrochloride trihydrate)

Adopted Reference Number: EMADOC-1700519818-2235447