EMEA-003513-PIP01-23 - paediatric investigation plan

transglutaminase 2 inhibitor

Key facts

• Active substance:
  transglutaminase 2 inhibitor
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0308/2024
• PIP number:
  EMEA-003513-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard Age-appropriate oral formulation
• 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:
  16/08/2024
• Compliance check done:
  Nem

Decision

P/0308/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for transglutaminase 2 inhibitor (EMEA-003513-PIP01-23)

Adopted Reference Number: EMA/364889/2024