Composition

Phesgo 600 mg/600 mg solution for injection. One vial of 10 mL solution contains 600 mg of Pertuzumab and 600 mg of Trastuzumab. Each mL of solution contains 60 mg of Pertuzumab and 60 mg of Trastuzumab. Pertuzumab and Trastuzumab are humanized immunoglobulin (Ig)G1 monoclonal antibodies produced in mammalian (Chinese hamster ovary) cells by recombinant deoxyribonucleic acid (DNA) technology Excipients: Human hyaluronidase (rHuPH20) (produced by recombinant DNA technology using CHO [Chinese hamster ovary] cells), L-histidine hydrochloride monohydrate 36.1 mg, L-histidine 4.40 mg, a,a-Trehalose dehydrate 397 mg, Sucrose 342 mg, Polysorbate 20* 4.00 mg, L-methionine 14.9 mg, Water for Injection q.s. to 10 mL  

ATC Code

L01XY02  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

10 mL x 1’s (in vial)  

Product Description

Solution for injection. Clear to opalescent solution, colourless to slightly brownish, pH 5.2-5.8, osmolality of 270-370 and 275-375 mOsmol/kg for the 1200 mg/600 mg and 600 mg/600 mg solutions, respectively

Manufacturer Name

F. Hoffmann-La Roche Ltd

Manufacturer Country

SWITZERLAND  

Approval Date

2022-11-02  

Expiry Date

2027-11-01