Swedish Orphan Biovitrum Pty Ltd
Regulatory activities for this sponsor.
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11 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Swedish Orphan Biovitrum Pty Ltd - Mechanically-operated infusion pump set.
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Prescription medicine registrationActive ingredients: pegcetacoplan.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Swedish Orphan Biovitrum Pty Ltd - Mechanically-operated infusion pump.
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Designation or determinationOrphan drug
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Designation or determinationProvisional determination
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Australian Public Assessment Report (AusPAR)Doptelet (avatrombopag) has been approved for the treatment of thrombocytopenia in adult patients with chronic liver disease and chronic immune thrombocytopenia.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for DOPTELET avatrombopag (as maleate) 20 mg film-coated tablets blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for EMPAVELI pegcetacoplan 1080 mg/20 mL injection solution vial.
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Prescription medicine decision summaryDoptelet (avatrombopag maleate) is approved to treat thrombocytopenia in adult patients.
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Prescription medicine registrationActive ingredients: avatrombopag maleate.