EMA/PE/0000241632 - paediatric investigation plan

linaprazan glurate

Key facts

• Active substance:
  linaprazan glurate
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000241632
• PIP number:
  EMA/PE/0000241632
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Helicobacter pylori infection
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000241632 : EMA decision of 12 June 2025 on the granting of a product specific waiver for linaprazan glurate

Adopted Reference Number: EMADOC-1700519818-2183392