EMEA-000645-PIP03-18
Key facts
| Invented name |
Entyvio
|
| Active substance |
vedolizumab
|
| Therapeutic area |
|
| Decision number |
P/0276/2019
|
| PIP number |
EMEA-000645-PIP03-18
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Prevention of acute graft-versus-host disease
|
| Route(s) of administration |
|
| Contact for public enquiries |
Takeda Pharma A/S
Tel. +44 2031168000 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Decision
-
List item
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) (PDF/257.36 KB)
Adopted
First published: 20/11/2019
EMA/395100/2019 -
List item
Vedolizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (PDF/236.18 KB)
First published: 09/11/2022