Manufacturing Establishments (4)
F. Hoffmann-La Roche Ltd
Genentech, Inc.
485244961
Roche Diagnostics GmbH
Genentech, Inc.
315028860
Roche Singapore Technical Operations Pte. Ltd.
Genentech, Inc.
937189173
Genentech, Inc.
Genentech, Inc.
146373191
Products (1)
Herceptin Hylecta
50242-077
BLA761106
BLA (C73585)
SUBCUTANEOUS
October 19, 2020
WATERInactive
Code: 059QF0KO0RClass: IACT
TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 600 mg in 5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 18.35 mg in 5 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 1.95 mg in 5 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 397.25 mg in 5 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 2 mg in 5 mL
METHIONINEInactive
Code: AE28F7PNPLClass: IACTQuantity: 7.45 mg in 5 mL
Code: 743QUY4VD8Class: ACTIBQuantity: 10000 U in 5 mL