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EYLEA Solution for injection (2018)

Active ingredients: Aflibercept

Product Name and Form

Eylea 40 mg/ml solution for injection in a vial.

Pharmaceutical form

Solution for injection (injection).

The solution is a clear, colourless to pale yellow and iso-osmotic solution.

Qualitative and Quantitative Composition

1 ml solution for injection contains 40 mg aflibercept*.

Each vial contains 100 microlitres, equivalent to 4 mg aflibercept. This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept.

* Fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Chemical substance
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

Polysorbate 20
Sodium dihydrogen phosphate, monohydrate (for pH adjustment)
Disodium hydrogen phosphate, heptahydrate (for pH adjustment)
Sodium chloride
Sucrose
Water for injection

Pack sizes and Marketing

100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle. Pack size of 1.

Marketing authorization holder
Authorization dates

Bayer AG, 51368, Leverkusen, Germany

Date of first authorisation: 22 November 2012
Date of latest renewal: 13 July 2017

Marketing authorization number:

EU/1/12/797/002