Australian Public Assessment Reports (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.

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.

WELIREG (belzutifan) is indicated for treatment of patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

Vaxneuvance, a vaccine, has been approved for the prevention of pneumococcal disease caused by Streptococcus pneumoniae.

AusPAR for Gardasil 9 (HPV 9-valent vaccine, recombinant) for prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by HPV in males.

Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

AusPAR for Keytruda (pembrolizumab) for the treatment of Oesophageal Cancer

AusPAR for Keytruda (pembrolizumab) for the treatment relapsed or refractory classical Hodgkin Lymphoma

AusPAR for Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

AusPAR for Vaxneuvance (pneumococcal 15-valent conjugate vaccine (CRM197 protein), adsorbed) for the prevention of pneumococcal disease.

Australian Public Assessment Report for Doravirine and doravirine/lamivudine/tenofovir disoproxil fumarate

Australian Public Assessment Report for Daptomycin

Australian Public Assessment Report for Pembrolizumab [Keytruda]

Australian Public Assessment Report for Pembrolizumab (rch)

Australian public assessment report for Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B)

Australian Public Assessment Report for Tafluprost/Timolol

Australian public assessment report for Ezetimibe / Rosuvastatin (as calcium)

Australian Public Assessment Report for Ezetimibe and rosuvastatin (as calcium)

Australian Public Assessment Report for Olmesartan medoxomil / Amlodipine (as besilate) / Hydrochlorothiazide

Australian Public Assessment Report for Ivermectin

Australian Public Assessment Report

Australian Public Assessment Report for Sitagliptin / Simvastatin

Australian Public Assessment Report for Raltegravir

Australian Public Assessment Report

Australian Public Assessment Report for Sitagliptin / Metformin