EMEA-003558-PIP01-23 - paediatric investigation plan

linaprazan glurate

Key facts

• Active substance:
  linaprazan glurate
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0392/2024
• PIP number:
  EMEA-003558-PIP01-23
• Pharmaceutical form(s):
  • Tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of gastro-oesophageal reflux disease
• 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:
  06/12/2024
• Compliance check done:
  No

Decision

P/0392/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for linaprazan glurate (EMEA-003558-PIP01-23)

Adopted Reference Number: EMA/554255/2024