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345 result(s) found, displaying 101 to 110
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Designation or determinationProvisional determination
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Australian Public Assessment Report (AusPAR)Imjudo (tremelimumab) is approved for the treatment of unresectable hepatocellular carcinoma.
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Australian Public Assessment Report (AusPAR)Imfinzi (Durvalumab) has been approved for the treatment of unresectable hepatocellular carcinoma.
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Australian Public Assessment Report (AusPAR)Andexxa (andexanet alfa) is provisionally approved for adult patients treated with a direct factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for BREZTRI AEROSPHERE 160/7.2/5 budesonide 160 mcg/glycopyrronium 7.2 mcg/formoterol fumarate dihydrate 5 mcg per actuation inhalation pMDI (DFP-EvoCap).
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Cancellation by sponsorRequested by AstraZeneca Pty Ltd
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SAPHNELO anifrolumab 300 mg concentrated injection vial.
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Prescription medicine decision summaryWe have provisionally approved Andexxa (andexanet alfa) for patients treated with a direct factor Xa inhibitor, when reversal of anticoagulation is needed.
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Prescription medicine registrationActive ingredients: dapagliflozin propanediol monohydrate.