EMEA-003116-PIP01-21 - paediatric investigation plan

Gliadin protease

Key facts

• Active Substance:
  Gliadin protease
• Therapeutic area:
  • Gastroentology-Hepatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0268/2022
• PIP number:
  EMEA-003116-PIP01-21
• Pharmaceutical form(s):
  Age appropriate oral solid pharmaceutical form
• Condition(s) / indication(s):
  Treatment of coeliac disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2022

Decision

P/0268/2022: EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for gliadin protease (EMEA-003116-PIP01-21)

Reference Number: EMA/662864/2022