EMEA-000055-PIP01-07-M06

Table of contents

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
Contact for public enquiries
Eisai Limited

E-mail: eumedinfo@eisai.net
Tel.: +44 845 6765400
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000055-PIP01-07-M06
Compliance opinion date
01/02/2019
Compliance outcome
positive

Decision

Topics

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