Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride - paediatric investigation plan

bismuth subcitrate potassium

Metronidazole

tetracycline hydrochloride

Key facts

• Active substance:
  • bismuth subcitrate potassium
  • Metronidazole
  • tetracycline hydrochloride
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/74/2009
• PIP number:
  Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  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:
  20/04/2009
• Compliance check done:
  No

Decision

P/74/2009: European Medicines Agency decision of 20 April 2009 on the granting of a product specific waiver for Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride (EMEA-000382-PIP01-08) in accordan...

Adopted Reference Number: EMEA/230384/2009