Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, Germany
Eylea 40 mg/mL solution for injection in pre-filled syringe.
| Pharmaceutical Form |
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Solution for injection (injection). The solution is a clear, colourless to pale yellow and iso-osmotic solution. |
1 mL solution for injection contains 40 mg aflibercept*.
One pre-filled syringe contains an extractable volume of at least 0.09 mL, equivalent to at least 3.6 mg aflibercept. This provides a usable amount to deliver a single dose of 0.05 mL containing 2 mg aflibercept to adult patients or a single dose of 0.01 mL containing 0.4 mg aflibercept to preterm infants.
* 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 |
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Polysorbate 20 (E432) |
Solution in pre-filled syringe (type I glass) marked with a dosing line, with a plunger stopper (elastomeric rubber) and a Luer lock adaptor with a tip cap (elastomeric rubber). Each pre-filled syringe contains an extractable volume of at least 0.09 mL. Pack size of 1 pre-filled syringe.
Bayer AG, 51368 Leverkusen, Germany
EU/1/12/797/001
Date of first authorisation: 22 November 2012
Date of latest renewal: 13 July 2017
| 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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