ENTYVIO Powder for concentrate for solution for infusion Ref.[8936] Active ingredients: Vedolizumab

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark

Product name and form

Entyvio 300 mg powder for concentrate for solution for infusion.

Pharmaceutical Form
Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder.

Qualitative and quantitative composition

Each vial contains 300 mg of vedolizumab.

After reconstitution, each mL contains 60 mg of vedolizumab.

Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.

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
L-histidine L-histidine monohydrochloride L-arginine hydrochloride Sucrose Polysorbate 80

Pack sizes and marketing

Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap.

Each pack contains 1 vial.

Marketing authorization holder

Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark

Marketing authorization dates and numbers

EU/1/14/923/001

Date of first authorisation: 22 May 2014
Date of latest renewal: 12 December 2018

Drugs

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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