Product Details
Vabysmo**
Faricimab6 mg/0.05 mL (120 mg/mL)
Solution for injection
ROA
Intravitreal
Applicant Name
Roche Products Limited
NRN
A6-100124
Status
Active
Composition
Vabysmo 120 mg/mL solution for injection. Each 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 *Faricimab is a humanized antibody produced in mammalian Chinese Hamster Ovary (CHO) cell culture by recombinant DNA technology Excipients: L-Histidine 155 mcg, Acetic Acid 30% q.s. to pH 5.5, L-Methionine 52.2 mcg, Sodium Chloride 73.1 mcg, D-Sucrose 2.74 mg, Polysorbate 20 20.00 mcg, Water for Injection q.s. to 0.05 mL
ATC Code
S01LA09
Product Category
Vaccines and Biologics
Marketing Category
Prescription-only Medicine (POM)
Packsize
0.24 mL x 1's (in glass vial) and one sterile 5 µm blunt transfer filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm) for single use
Product Description
Solution for Intravitreal Injection. Clear to opalescent, colourless to brownish-yellow solution, with a pH of 5.5 and an osmolality of 270-370 mOsm/kg
Manufacturer Name
F. Hoffmann-La Roche Ltd
Manufacturer Country
SWITZERLAND
Approval Date
2023-07-14
Expiry Date
2028-07-13