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38 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for LEQEMBI lecanemab 500 mg/5 mL concentrated injection vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for LEQEMBI lecanemab 200 mg/2 mL concentrated injection vial.
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Australian public assessment report (AusPar)Leqembi is indicated in adult patients with a diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. Beta amyloid evidence consistent with Alzheimer’s disease (AD) should be confirmed using a validated test prior to initiating treatment.
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Cancellation by sponsorRequested by Eisai Australia Pty Ltd
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for DAYVIGO lemborexant 5 mg film coated tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for DAYVIGO lemborexant 10 mg film coated tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for FYCOMPA perampanel (as hemisesquihydrate) 2 mg/4 mL oral suspension.
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Prescription medicine registrationActive ingredients: lenvatinib mesilate.
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Australian public assessment report (AusPar)New AusPAR for Dayvigo (lemborexant) for the treatment of insomnia.