Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 28.04 mg; rilpivirine hydrochloride, quantity: 27.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone; croscarmellose sodium; polysorbate 20; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma hiv-1 rna <= 100,000 copies/ml at the start of therapy. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of odefsey.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - sofosbuvir, quantity: 400 mg; ledipasvir acetone solvate, quantity: 95.9 mg (equivalent: ledipasvir, qty 90 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - harvoni (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis c (chc) infection in adults. (see precautions and clinical trials sections for information on the available data for hcv patients of each genotype, see dosage and administration section for recommended regimens and treatment durations for different patient subgroups).

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - idelalisib, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; sodium starch glycollate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - idelalisib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; hyprolose; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - ? zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - sofosbuvir -

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - aztreonam -

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose - treatment of hiv-1 infection,truvada is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - axicabtagene ciloleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; sodium chloride; dimethyl sulfoxide - cellular therapies - yescarta is a genetically modified autologous immunocellular therapy for the treatment of relapsed or refractory large b-cell lymphoma after two or more lines of systemic therapy, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, primary mediastinal large b-cell lymphoma, high grade b-cell lymphoma, and dlbcl arising from follicular lymphoma. yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; dimethyl sulfoxide; sodium chloride - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (mcl), who have received two or more lines of therapy, including a btk inhibitor, unless ineligible or intolerant to treatment with a btk inhibitor.