EMEA-000645-PIP01-09-M08

Table of contents

Key facts

Invented name
Entyvio
Active substance
vedolizumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0552/2021
PIP number
EMEA-000645-PIP01-09-M08
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Solution for injection in pre-filled syringe
Condition(s) / indication(s)
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
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
PM: decision on the application for modification of an agreed PIP

Decision

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