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29 result(s) found, displaying 1 to 10
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Designation or determinationProvisional determination
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Jul-2024Prescription medicine evaluationActive ingredient: omaveloxolone.
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Cancellation by sponsorRequested by Biogen Australia Pty Ltd
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Australian Public Assessment Report (AusPAR)AusPAR for withdrawn Aduhelm (aducanumab) for proposed treatment of Alzheimer’s disease.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for VUMERITY diroximel fumarate 231 mg enteric capsules bottle.
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Australian Public Assessment Report (AusPAR)New AusPAR for VUMERITY (diroximel fumarate) to reduce relapses and delay progression of disability in multiple sclerosis patients.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TYSABRI natalizumab 150 mg/1 mL injection solution pre-filled syringe.
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Cancellation by sponsorRequested by Biogen Australia Pty Ltd