ZALTRAP Concentrate for solution for infusion Ref.[7452] Active ingredients: Aflibercept

Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France

Product name and form

ZALTRAP 25 mg/ml concentrate for solution for infusion.

Pharmaceutical Form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow solution.

Qualitative and quantitative composition

One ml of concentrate for solution for infusion contains 25 mg aflibercept*.

One vial of 4 ml of concentrate contains 100 mg of aflibercept.
One vial of 8 ml of concentrate contains 200 mg of aflibercept.

* Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Aflibercept	Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1. Aflibercept blocks the activation of VEGF receptors and the proliferation of endothelial cells, thereby inhibiting the growth of new vessels that supply tumours with oxygen and nutrients.

List of Excipients
Sucrose Sodium chloride Sodium citrate dihydrate Citric acid monohydrate Polysorbate 20 Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections

Pack sizes and marketing

4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. Pack size of 1 vial or 3 vials.
8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. Pack size of 1 vial.

Not all pack sizes may be marketed.

Marketing authorization holder

sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France

Marketing authorization dates and numbers

EU/1/12/814/001
EU/1/12/814/002
EU/1/12/814/003

Date of first authorisation: 01 February 2013

Drugs

Drug	Countries
ZALTRAP	Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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