EMEA-002757-PIP02-21 - paediatric investigation plan

Izencitinib

Key facts

• Active Substance:
  Izencitinib
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0018/2022
• PIP number:
  EMEA-002757-PIP02-21
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Theravance Biopharma Ireland Limited

  Email: [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:
  31/01/2022

Decision

P/0018/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for izencitinib (EMEA-002757-PIP02-21)

AdoptedReference Number: EMA/8212/2022