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Sponsor content
536 result(s) found, displaying 181 to 190
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Section 14, TGO91 consentProduct(s) approved for Supply with noncompliant labelling.
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Section 14, TGO91 consentProduct(s) approved for Supply with noncompliant labelling.
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Prescription medicine decision summaryTGA decision: Luxturna (voretigene neparvovec) is approved to treat inherited retinal dystrophy caused by RPE65 mutations
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Prescription medicine registrationActive ingredients: voretigene neparvovec.
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Designation or determinationOrphan drug
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Prescription medicine registrationActive ingredients: indacaterol acetate; mometasone furoate.
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Australian Public Assessment Report (AusPAR)Australian Public Assessment Report for Ribociclib succinate
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled pen.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled syringe.
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Cancellation by sponsorRequested by Novartis Pharmaceuticals Australia Pty Ltd