Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Bayer AG, 51368 Leverkusen, Germany
Eylea 114.3 mg/ml solution for injection.
Eylea 114.3 mg/ml solution for injection in pre-filled syringe.
| Pharmaceutical Form |
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Solution for injection (injection). Clear to slightly opalescent, colourless to pale yellow, iso-osmotic solution, pH 5.8. |
1 ml solution for injection contains 114.3 mg aflibercept*.
Eylea 114.3 mg/ml solution for injection: 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.
Eylea 114.3 mg/ml solution for injection in pre-filled syringe: Each pre-filled syringe contains 21 mg aflibercept in 0.184 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.
Excipient with known effect:
Each ml solution for injection contains 0.3 mg polysorbate 20 (E432).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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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Sucrose |
Eylea 114.3 mg/ml solution for injection:
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.
Eylea 114.3 mg/ml solution for injection in pre-filled syringe:
Pre-filled syringe (type I glass) with a grey plunger stopper (elastomeric rubber), a white Luer-lock adaptor with a grey tip cap (elastomeric rubber) and a blue OcuClick dosing system (PC/ABS plastic).
Each pre-filled syringe contains 0.184 ml solution.
Pack size of 1 pre-filled syringe.
Bayer AG, 51368 Leverkusen, Germany
EU/1/12/797/003
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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