The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
GlaxoSmithKline Australia Pty Ltd
Regulatory activities for this sponsor.
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418 result(s) found, displaying 1 to 10
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Australian Public Assessment Report (AusPAR)Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
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Prescription medicine registrationActive ingredients: recombinant respiratory syncytial virus pre-fusion F protein.
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Cancellation by sponsorRequested by GlaxoSmithKline Australia Pty Ltd
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Cancellation by sponsorRequested by GlaxoSmithKline Australia Pty Ltd
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Prescription medicine registrationActive ingredients: Diphtheria toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis toxoid, Poliovirus, Tetanus toxoid.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 100 mg film-coated tablet bottle.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 200 mg film-coated tablet bottle.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 150 mg film-coated tablet bottle.
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Cancellation by sponsorRequested by GlaxoSmithKline Australia Pty Ltd
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Cancellation by sponsorRequested by GlaxoSmithKline Australia Pty Ltd