AstraZeneca Pty Ltd
Regulatory activities for this sponsor.
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317 result(s) found, displaying 71 to 80
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for RILAST RAPIHALER budesonide / formoterol fumarate dihydrate 100/3 pressurised metered dose inhaler.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for RILAST RAPIHALER budesonide / formoterol fumarate dihydrate 200/6 pressurised metered dose inhaler.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for CALQUENCE acalabrutinib (as maleate) 100 mg film-coated tablet blister pack.
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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.
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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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Prescription medicine decision summaryThe medicine Imjudo (tremelimumab), in combination with durvalumab, is approved to treat adult patients with unresectable hepatocellular carcinoma (uHCC).
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Prescription medicine registrationActive ingredients: andexanet alfa.
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