EMEA-000645-PIP03-18

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. +44 2031168000
E-mail: paediatrics@tgrd.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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