Esomeprazole magnesium/acetylsalisylic acid - paediatric investigation plan

esomeprazole magnesium

acetylsalicylic acid

Key facts

• Active substance:
  • esomeprazole magnesium
  • acetylsalicylic acid
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/59/2010
• PIP number:
  Esomeprazole magnesium/acetylsalisylic acid
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  • Duodenal ulcer
  • Gastric ulcer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/03/2010
• Compliance check done:
  Όχι

Decision

P/59/2010: European Medicines Agency decision of 29 March 2010 on the granting of a product specific waiver for esomeprazole magnesium/acetylsalisylic acid (EMEA-000682-PIP01-09) in accordance with Regulation (EC) No 19...

Reference Number: EMA/202139/2010