EMEA-000645-PIP03-18 - paediatric investigation plan

vedolizumab

Key facts

• Invented name:
  Entyvio
• Active Substance:
  vedolizumab
• Therapeutic area:
  • Gastroentology-Hepatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0276/2019
• PIP number:
  EMEA-000645-PIP03-18
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Prevention of acute graft-versus-host disease
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Takeda Pharma A/S

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/08/2019

Decision

P/0276/2019: EMA decision of 14 August 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vedolizumab (Entyvio) (EMEA-000645-PIP03-18)

AdoptedReference Number: EMA/395100/2019

Vedolizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision