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21 result(s) found, displaying 11 to 20
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Designation or determinationProvisional determination
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Prescription medicine registrationActive ingredients: tebentafusp.
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Prescription medicine decision summaryTGA decision: KIMMTRAK (tebentafusp) is approved to treat unresectable or metastatic uveal melanoma in HLA-A*02:01 positive patient.
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Prescription medicine decision summaryTGA decision: Truseltiq (infigratinib) is approved to treat cholangiocarcinoma.
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Prescription medicine registrationActive ingredients: infigratinib.
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Designation or determinationPriority review
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Designation or determinationProvisional approval