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23 result(s) found, displaying 11 to 20
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Australian public assessment report (AusPar)AusPAR for SOGROYA (somapacitan) indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency.
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Designation or determinationOrphan drug
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Designation or determinationPriority review
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Cancellation by sponsorRequested by Novo Nordisk Pharmaceuticals Pty Ltd
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Cancellation by sponsorRequested by Novo Nordisk Pharmaceuticals Pty Ltd
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Cancellation by sponsorRequested by Novo Nordisk Pharmaceuticals Pty Ltd
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Prescription medicine registrationActive ingredients: Semaglutide.
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Prescription medicine decision summaryTGA decision: Sogroya (somapacitan) is approved to treat adults with growth hormone deficiency (AGHD).
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Prescription medicine decision summaryTGA decision: Rybelsus (semaglutide) is approved to treat type 2 diabetes mellitus
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Prescription medicine registrationActive ingredients: somapacitan.