MedPath
FDA Approval

OCREVUS

January 25, 2024

HUMAN PRESCRIPTION DRUG LABEL

Ocrelizumab(300 mg in 10 mL)

Manufacturing Establishments (4)

Roche Singapore Technical Operations Pte. Ltd.

Genentech, Inc.

937189173

Genentech, Inc.

Genentech, Inc.

004074162

F. Hoffmann-La Roche Ltd

Genentech, Inc.

485244961

Roche Diagnostics GmbH

Genentech, Inc.

323105205

Products (1)

OCREVUS

50242-150

BLA761053

BLA (C73585)

INTRAVENOUS

January 25, 2024

SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 21.4 mg in 10 mL
Code: A10SJL62JYClass: ACTIBQuantity: 300 mg in 10 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 2.5 mg in 10 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 400 mg in 10 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 2 mg in 10 mL
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