Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Yesafili 40 mg/mL solution for injection in a vial.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless to pale yellow and iso-osmotic solution. |
1 mL solution for injection contains 40 mg aflibercept*.
One vial contains an extractable volume of at least 0.1 mL, equivalent to at least 4 mg aflibercept. This provides a usable amount to deliver a single dose of 0.05 mL 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.
| 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 |
|---|
|
Histidine |
Solution in a vial (type I glass) with a stopper (chlorobutyl rubber). Each vial contains an extractable volume of at least 0.1 mL.
Yesafili is available in 2 different packs:
One pack containing 1 vial and a 5-micron sterile filter needle (18 G × 1½-inch).
One pack containing 1 vial, a 5-micron sterile filter needle (18 G × 1½-inch), a 1 mL Luer-lock syringe and an injection needle (30 G × ½-inch).
Not all pack sizes may be marketed.
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
EU/1/23/1751/001
EU/1/23/1751/002
| Drug | Countries | |
|---|---|---|
| YESAFILI | Austria, Estonia, Croatia, Ireland, Lithuania, United States |
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