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49 result(s) found, displaying 1 to 10
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Australian Public Assessment Report (AusPAR)Filsuvez is approved for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for FILSUVEZ birch bark dry extract (84-95% triterpenes) 100 mg/g gel tube.
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ALKINDI hydrocortisone 2 mg granules (in capsule) bottle Cancelled under Section 30(1)(c) of the Act
Cancellation by sponsorRequested by Chiesi Australia Pty Ltd -
ALKINDI hydrocortisone 5 mg granules (in capsule) bottle Cancelled under Section 30(1)(c) of the Act
Cancellation by sponsorRequested by Chiesi Australia Pty Ltd -
Cancellation by sponsorRequested by Chiesi Australia Pty Ltd
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ALKINDI hydrocortisone 1 mg granules (in capsule) bottle Cancelled under Section 30(1)(c) of the Act
Cancellation by sponsorRequested by Chiesi Australia Pty Ltd -
Prescription medicine decision summaryFilsuvez (Birch bark dry extract - 84-95% triterpenes) has been approved for the treatment of partial-thickness wounds of the skin associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
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Prescription medicine registrationActive ingredients: birch bark dry extract (84-95 per cent) triterpenes.
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Australian Public Assessment Report (AusPAR)Elfabrio (pegunigalsidase alfa) has been approved for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
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Mar-2026Prescription medicine evaluationActive ingredient: idebenone.