Composition

Each pre-filled syringe (PFS) contains 120 mg of Satralizumab in 1 mL. Satralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology Excipients: L-Histidine 3.1 mg, L-Aspartic Acid q.s. to pH 6.0, L-Arginine 26.1 mg, Poloxamer 188 0.5 mg, Water for injection q.s. to 1 mL  

ATC Code

L04AC19  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 mL x 1's (in pre-filled syringe)  

Product Description

Solution for injection in 1-mL single-dose pre-filled syringe (PFS). Colourless to slightly yellow liquid. The solution has a pH of approximately 6.0 and an osmolality of approximately 310 mOsm/kg

Manufacturer Name

Chugai Pharma Manufacturing Co. Ltd Utsunomiya Plant

Manufacturer Country

JAPAN  

Approval Date

2023-08-31  

Expiry Date

2028-08-30