EMEA-000055-PIP01-07-M06 - paediatric investigation plan

rabeprazole (sodium)

Key facts

• Invented name:
  Pariet and associated names
• Active substance:
  rabeprazole (sodium)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0401/2018
• PIP number:
  EMEA-000055-PIP01-07-M06
• Pharmaceutical form(s):
  • Gastro-resistant granules
  • Gastro-resistant tablet
• Condition(s) / indication(s):
  • Treatment of duodenal ulcer
  • Treatment of gastric ulcer
  • Treatment of gastro-oesophageal reflux disease
  • Treatment of Helicobacter pylori in patients with peptic ulcer disease
  • Treatment of Zollinger-Ellison syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2018
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000055-PIP01-07-M06
• Compliance opinion date:
  01/02/2019
• Compliance outcome:
  Positive

Decision

P/0401/2018: EMA decision of 3 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for rabeprazole (sodium) (Pariet and associated names), (EMEA-000055-PIP01-07-M06)

Adopted Reference Number: EMA/823217/2018