Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639, Germany
Vabysmo 120 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection. Clear to opalescent, colourless to brownish-yellow solution, with a pH of 5.5 and an osmolality of 270-370 mOsm/kg. |
Faricimab is a humanised antibody produced in mammalian Chinese Hamster Ovary (CHO) cell culture by recombinant DNA technology.
One mL of solution contains 120 mg of faricimab.
Each vial contains 28.8 mg faricimab in 0.24 mL solution. This provides a usable amount to deliver a single dose of 0.05 mL solution containing 6 mg of faricimab.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Faricimab |
Faricimab is a humanised bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of two distinct pathways by neutralisation of both angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A). By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability. |
| List of Excipients |
|---|
|
L-histidine |
0.24 mL sterile, solution in a glass vial with a coated rubber stopper sealed with an aluminum cap with a yellow plastic flip-off disk.
Pack size of 1 vial and 1 blunt transfer filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm, 5 µm).
Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639, Germany
EU/1/22/1683/001
| Drug | Countries | |
|---|---|---|
| VABYSMO | Austria, Canada, Ecuador, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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