Celltrion Healthcare Australia Pty Ltd
Regulatory activities for this sponsor.
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Sponsor content
58 result(s) found, displaying 41 to 50
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for REMSIMA infliximab 120 mg solution for injection prefilled syringe with safety guard.
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Prescription medicine decision summaryTGA Decision: Yuflyma (adalimumab) is approved to treat multiple auto-immune conditions.
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Prescription medicine registrationActive ingredients: adalimumab.
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Australian Public Assessment Report (AusPAR)Australian Public Assessment Report for Regdanvimab
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Prescription medicine registrationActive ingredients: regdanvimab.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HERZUMA trastuzumab (rch) 440 mg powder for injection for intravenous infusion vial with diluent.
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Designation or determinationProvisional approval
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HERZUMA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TRUXIMA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion.