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THYMOGLOBULINE Powder for solution for infusion (2019)

Active ingredients: Antithymocyte immunoglobulin

Product Name and Form

Thymoglobuline 25 mg powder for solution for infusion.

Pharmaceutical form

Powder for solution for infusion.

Qualitative and Quantitative Composition

Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Antithymocyte immunoglobulin

Antithymocyte immunoglobulin is a selective immunosuppressive agent mostly acting on T lymphocytes. Antithymocyte immunoglobulin is used for the prevention and treatment of graft rejection after solid organ transplantation, usually in combination with other immunosuppressive drugs.

List of excipients

Glycine
Sodium chloride
Mannitol

Other components:

Thymoglobuline may also contain residues of polysorbate, from the manufacturing process.

Pack sizes and Marketing

Powder in a vial (type I glass) closed with a stopper (chlorobutyl). Each pack contains one 10 ml vial.

Marketing authorization holder
Authorization dates

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands

18/03/2013

Marketing authorization number:

PL 12375/0021