Sponsor content
33 result(s) found, displaying 1 to 10
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Australian public assessment report (AusPar)Skyclarys has been approved for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for QALSODY tofersen 100 mg/15 mL solution for injection vial.
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Prescription medicine decision summaryQalsody has been provisionally approved for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. ALS is a type of motor neurone disease (MND).
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SKYCLARYS omaveloxolone 50 mg capsule bottle.
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Prescription medicine registrationActive ingredients: omaveloxolone.
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Designation or determinationProvisional determination
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Cancellation by sponsorRequested by Biogen Australia Pty Ltd