EMEA-000645-PIP04-20-M02 - paediatric investigation plan
vedolizumab
PIPHuman
Key facts
Invented name
Entyvio
Active Substance
vedolizumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0382/2023
PIP number
EMEA-000645-PIP04-20-M02
Pharmaceutical form(s)
Powder for concentrate for solution for infusion
Solution for injection
Condition(s) / indication(s)
Treatment of pouchitis
Route(s) of administration
Intravenous use
Subcutaneous use
Contact for public enquiries
Takeda Pharma A/S
E-mail: paediatrics@tgrd.com Tel. +44 2031168000
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0382/2023 : EMA decision of 7 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio) (EMEA-000645-PIP04-20-M02)