EYLEA 114.3 mg/ml Solution for injection Ref.[110823] Active ingredients: Aflibercept

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

Eylea 114.3 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to pale yellow, iso-osmotic solution, pH 5.8.

Qualitative and quantitative composition

1 ml solution for injection contains 114.3 mg aflibercept*.

Each vial contains 30.1 mg aflibercept in 0.263 ml solution. This provides a usable amount to deliver a single dose of 0.07 ml containing 8 mg aflibercept.

* Aflibercept is a 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.

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
Arginine hydrochloride
Histidine hydrochloride monohydrate
Histidine
Polysorbate 20
Water for injections

Pack sizes and marketing

Vial (type I glass) with a grey rubber stopper (chlorobutyl) sealed with an aluminium cap with white lid, and a 18 G, 5-micron filter needle.

Each vial contains 0.263 ml solution.

Pack size of 1 vial and 1 filter needle.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/12/797/003

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

Drugs

Drug Countries
EYLEA Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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