EMEA-002703-PIP01-19 - paediatric investigation plan

Vonoprazan

Key facts

• Active Substance:
  Vonoprazan
• Therapeutic area:
  • Gastroentology-Hepatology
  • Infectious diseases
• Decision number:
  P/0454/2020
• PIP number:
  EMEA-002703-PIP01-19
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
  • Age-appropriate dosage form
• Condition(s) / indication(s):
  • Treatment of gastroesophageal reflux disease
  • Treatment of Helicobacter pylori infection
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Phathom Pharmaceuticals, Inc.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/12/2020

Decision

P/0454/2020 : EMA decision of 4 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vonoprazan (EMEA-002703-PIP01-19)

AdoptedReference Number: EMA/581093/2020