Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
Entyvio 108 mg solution for injection in pre-filled syringe.
Entyvio 108 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless to yellow solution. |
Entyvio 108 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 108 mg of vedolizumab in 0.68 mL.
Entyvio 108 mg solution for injection in pre-filled pen: Each pre-filled pen contains 108 mg of vedolizumab in 0.68 mL.
Vedolizumab is a humanised IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vedolizumab |
Vedolizumab is a gut-selective immunosuppressive biologic. It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes. By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1). |
| List of Excipients |
|---|
|
Citric acid monohydrate |
Entyvio 108 mg solution for injection in pre-filled syringe:
Solution for injection in a Type I glass 1 mL syringe with a fixed 27 gauge thin wall, 1.27 cm needle.
The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled syringe is a single dose, disposable drug delivery system with manual injection operation. Each pre-filled syringe is equipped with a safety device that activates to extend and lock a guard over the needle once the injection is completed.
Packs of 1 or 2 pre-filled syringes, and multipacks of 6 (6 packs of 1) pre-filled syringes.
Entyvio 108 mg solution for injection in pre-filled pen:
Solution for injection in a pre-filled pen in a Type I glass 1 mL syringe and a fixed 27 gauge thin wall, 1.27 cm needle. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled pen is a single dose, disposable drug delivery system with mechanical injection operation. Each pre-filled pen is equipped with an automated needle shield to extend and lock over the needle once the device is removed from the injection site.
Packs of 1 or 2 pre-filled pens, and multipacks of 6 (6 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark, medinfoEMEA@takeda.com
Entyvio 108 mg solution for injection in pre-filled syringe:
EU/1/14/923/002: 1 pre-filled syringe
EU/1/14/923/003: 2 pre-filled syringes
EU/1/14/923/004 Multipack: 6 (6 packs of 1) pre-filled syringes
Entyvio 108 mg solution for injection in pre-filled pen:
EU/1/14/923/005: 1 pre-filled pen
EU/1/14/923/006: 2 pre-filled pens
EU/1/14/923/007 Multipack: 6 (6 packs of 1) pre-filled pens
Date of first authorisation: 22 May 2014
Date of latest renewal: 12 December 2018
| Drug | Countries | |
|---|---|---|
| ENTYVIO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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