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352 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ENFLONSIA clesrovimab 105 mg in 0.7 mL solution for injection prefilled syringe.
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Prescription medicine decision summaryEnflonsia has been approved to help prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.
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Cancellation by sponsorRequested by Merck Sharp & Dohme (Australia) Pty Ltd
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Prescription medicine registrationActive ingredients: pembrolizumab.
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Jan-2026Prescription medicine evaluationActive ingredient: pembrolizumab.
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Dec-2025Prescription medicine evaluationActive ingredient: Pneumococcal purified capsular polysaccharides.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for WELIREG belzutifan 40 mg film-coated tablet blister pack.
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Oct-2025Prescription medicine evaluationActive ingredient: pembrolizumab.
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Australian public assessment report (AusPar)Capvaxive is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older.
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Australian public assessment report (AusPar)Winrevair (sotatercept) has been approved for the treatment of adults with pulmonary arterial hypertension (PAH) in WHO Functional Class (FC) II or III, in combination with standard therapy.