MedPath
FDA Approval

Phesgo

November 16, 2022

HUMAN PRESCRIPTION DRUG LABEL

Pertuzumab(600 mg in 10 mL)
Trastuzumab(600 mg in 10 mL)

Manufacturing Establishments (3)

Genentech, Inc.

Genentech, Inc.

146373191

Roche Diagnostics GmbH

Genentech, Inc.

315028860

F. Hoffmann-La Roche Ltd.

Genentech, Inc.

485244961

Products (2)

Phesgo

50242-260

BLA761170

BLA (C73585)

SUBCUTANEOUS

November 16, 2022

Code: K16AIQ8CTMClass: ACTIBQuantity: 600 mg in 10 mL
Code: P188ANX8CKClass: ACTIBQuantity: 600 mg in 10 mL
Code: 743QUY4VD8Class: ACTIBQuantity: 20000 U in 10 mL
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT

Phesgo

50242-245

BLA761170

BLA (C73585)

SUBCUTANEOUS

November 16, 2022

Code: P188ANX8CKClass: ACTIBQuantity: 600 mg in 15 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Code: K16AIQ8CTMClass: ACTIBQuantity: 1200 mg in 15 mL
Code: 743QUY4VD8Class: ACTIBQuantity: 30000 U in 15 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
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