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

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, 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.

Excipient(s) with known effect:

Each 4 ml vial contains 0.484 mmol of sodium, which is 11.118 mg of sodium, and 8 ml vial contains 0.967 mmol of sodium, which is 22.236 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient

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 Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, 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
Date of latest renewal: 21 September 2017

Drugs

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