The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Samsung Bioepis AU Pty Ltd
Regulatory activities for this sponsor.
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20 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for EPYZTEK ustekinumab 45 mg/0.5mL solution for injection pre-filled syringe.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for EPYZTEK ustekinumab 90 mg/1 mL solution for injection pre-filled syringe.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ONBEVZI bevacizumab 100 mg/4mL concentrated injection for intravenous infusion vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ONBEVZI bevacizumab 400 mg/16mL concentrated injection for intravenous infusion vial.
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Australian Public Assessment Report (AusPAR)Onbevzi (bevacizumab) is a biosimilar of Avastin. Onbevzi has been approved to treat a range of cancers either as a monotherapy or in combination with other anti-cancer medicines
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HADLIMA adalimumab 40 mg/0.4 mL solution for injection in pre-filled syringe.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Samsung Bioepis AU Pty Ltd - Surgical procedure kit, ophthalmic, medicated, single-use.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for BYOOVIZ ranibizumab 10 mg/mL solution for injection vial.