EMEA-000331-PIP01-08-M01 - paediatric investigation plan

esomeprazole magnesium trihydrate

esomeprazole sodium

Key facts

• Invented name:
  • Nexium and associated names
  • Nexium Control
• Active substance:
  • esomeprazole magnesium trihydrate
  • esomeprazole sodium
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/209/2009
• PIP number:
  EMEA-000331-PIP01-08-M01
• Pharmaceutical form(s):
  • Gastro-resistant tablet
  • Gastro-resistant granules for oral suspension
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  • Duodenal ulcer
  • Gastric ulcer
  • Gastro-oesophageal reflux disease
  • Peptic ulcer, site unspecified
  • Zollinger-Ellison syndrome
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2009
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000331-PIP01-08-M01
• Compliance opinion date:
  16/07/2010
• Compliance outcome:
  Positive

Decision

P/209/2009: European Medicines Agency decision of 30 October 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for esomeprazole sodium, esomeprazole magnesium trihydrate (Nexium and asso...

Adopted Reference Number: EMEA/688217/2009