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AusPAR: Gemtuzumab ozogamicin

Australian Public Assessment Report

AusPAR

AusPAR: Gemtuzumab ozogamicin [PDF, 732.24 KB]

AusPAR: Gemtuzumab ozogamicin [Word, 1.42 MB]

Attachment: Product Information for Gemtuzumab ozogamicin [PDF, 316.29 KB]

Attachment: Product Information for Gemtuzumab ozogamicin [Word, 198.84 KB]

Device/Product Name

Mylotarg

Active ingredients

Gemtuzumab ozogamicin

AusPAR Date

8 October 2020

Published

20 October 2020

Submission Number

PM-2019-01426-1-6

Submission Type

New biological entity

Decision

Approved