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68 result(s) found, displaying 1 to 10
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Australian public assessment report (AusPar)Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.
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Australian public assessment report (AusPar)Litfulo (ritlecitinib) has been approved for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.
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Australian public assessment report (AusPar)The Comirnaty JN.1 vaccine (Bretovameran), adapted to the SARS-CoV-2 Omicron JN.1 strain, has been approved to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 6 months of age and older.
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Australian public assessment report (AusPar)Elrexfio (elranatamab) was provisionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have demonstrated disease progression on the last therapy.
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Australian public assessment report (AusPar)Paxlovid (nirmatrelvir and ritonavir) was approved for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.
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Australian public assessment report (AusPar)Comirnaty Original/Omicron BA.4-5 Vaccine was provisionally approved for immunisation against coronavirus disease 2019 (COVID-19) caused by SARSCoV-2 in individuals 6 months of age or older.
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Australian public assessment report (AusPar)Velsipity (etrasimod) was approved for the treatment of adults with moderately to severely active ulcerative colitis who have not benefited from prior therapies
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Australian public assessment report (AusPar)Xeljanz (tofacitinib) was approved for the treatment of ankylosing spondylitis and for active polyarticular course juvenile idiopathic arthritis.
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Australian public assessment report (AusPar)Cibinqo (abrocitinib) has been approved for the treatment of moderate-to-severe atopic dermatitis in adults.
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Australian public assessment report (AusPar)Tukysa (tucatinib) has been approved to be used in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2 positive unresectable or metastatic colorectal cancer.