EMEA-002703-PIP01-19-M01 - paediatric investigation plan

vonoprazan

Key facts

• Active substance:
  vonoprazan
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0277/2024
• PIP number:
  EMEA-002703-PIP01-19-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate dosage form
• Condition(s) / indication(s):
  • Treatment of gastroesophageal reflux disease
  • Treatment of Helicobacter pylori infection
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2024
• Compliance check done:
  No

Decision

P/0277/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vonoprazan (EMEA-002703-PIP01-19-M01)

Adopted Reference Number: EMA/307256/2024