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HSA Approval

COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

Approval Number

SIN16968P

Drug Name

COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

Product Name

COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

Approval Date

March 5, 2024

Registrant

ROCHE SINGAPORE PTE. LTD.

Regulatory Information

Registrant

ROCHE SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INFUSION, SOLUTION CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01FX28

ATC Item Name

glofitamab

Manufacturer Information

Pharmaceutical Manufacturer

ROCHE SINGAPORE PTE. LTD.

Manufacturers

Genentech, Inc. (Bulk production and primary packing)

Active Ingredients

Ingredient Name

Glofitamab

Strength

1 mg/ml

Drug MonographGlofitamab

Documents

Package Inserts

Columvi Concentrate for Solution for Infusion PI.pdf

Approved: March 5, 2024

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