EMEA-003224-PIP01-22 - paediatric investigation plan

bismuth (subcitrate)

Metronidazole (benzoate)

Tetracycline (hydrochloride)

Key facts

• Active Substance:
  • bismuth (subcitrate)
  • Metronidazole (benzoate)
  • Tetracycline (hydrochloride)
• Therapeutic area:
  • Gastroentology-Hepatology
  • Infectious diseases
• Decision number:
  P/0371/2022
• PIP number:
  EMEA-003224-PIP01-22
• Pharmaceutical form(s):
  Granules
• Condition(s) / indication(s):
  Treatment of 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:
  09/09/2022

Decision

P/0371/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for bismuth (subcitrate) / metronidazole (benzoate) / tetracycline (hydrochloride) (EMEA-003224-PIP01-22)

AdoptedReference Number: EMA/697764/2022