Composition

Each 11.7-mL vial contains: Rituximab 1440 mg (120 mg/mL). MabThera SC formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. Not suitable for intravenous use Excipients: Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, trehalose dehydrate, L-methionine, polysorbate 80, Water for Injection  

ATC Code

L01FA01  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

11.7 mL (1440 mg) x 1’s (in clear glass vial)  

Product Description

Sterile, preservative-free, non-pyrogenic solution for injection in single-use 11.7-mL vial. Clear to opalescent, colourless to yellowish liquid with pH of 5.2 – 5.8 and osmolality of 300 – 400 mOsmol/kg

Manufacturer Name

F. Hoffmann-La Roche Ltd

Manufacturer Country

SWITZERLAND  

Approval Date

2023-06-06  

Expiry Date

2028-05-30