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31 result(s) found, displaying 1 to 10
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Australian public assessment report (AusPar)Niktimvo (axatilimab) has been approved for the treatment of chronic graft-versus host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for NIKTIMVO axatilimab 22 mg / 0.44 mL solution for injection glass vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for NIKTIMVO axatilimab 9 mg / 0.18 mL solution for injection glass vial.
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Designation or determinationOrphan drug
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Prescription medicine decision summaryNiktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.
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Prescription medicine registrationActive ingredients: axatilimab.
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Prescription medicine registrationActive ingredients: tafasitamab.
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Designation or determinationOrphan drug
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Jun-2025Prescription medicine evaluationActive ingredient: retifanlimab.
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Designation or determinationPriority review