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HSA Approval

DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

SIN17234P

DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

May 10, 2025

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

ASTRAZENECA SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

INTRAVENOUS

Medical Information

Pending

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

Baxter Oncology GmbH

Active Ingredients

datopotamab deruxtecan

100 mg/vial

Datopotamab deruxtecan

Documents

Package Inserts

Datroway PI May 2025.pdf

Approved: May 10, 2025

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DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL - HSA Approval | MedPath