Product Details

Vabysmo**

Faricimab
6 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