Israel - English - Ministry of Health

gilead sciences israel ltd - axicabtagene ciloleucel - dispersion for infusion - axicabtagene ciloleucel - yescarta is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and primary mediastinal large b-cell lymphoma (pmbcl), after two or more lines of systemic therapy. limitation of use :yescarta is not indicated for the treatment of patients with primary or secondary central nervous system lymphoma.yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

European Union - English - EMA (European Medicines Agency)

gilead sciences international limited - cidofovir - cytomegalovirus retinitis - antivirals for systemic use - vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (aids) and without renal dysfunction. vistide should be used only when other agents are considered unsuitable.,

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

gilead sciences pty ltd - velpatasvir, quantity: 100 mg; sofosbuvir, quantity: 400 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; copovidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide red; macrogol 4000; polyvinyl alcohol - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 dose and method of administration section for the recommended regimens for different patient subgroups).

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 - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 11.2 mg (equivalent: tenofovir alafenamide, qty 10 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; iron oxide black - treatment of hiv-1 infection: descovy is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25kg. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of descovy (see section 5.1 pharmacodynamic properties).,hiv-1 pre-exposure prophylaxis: descovy is indicated for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 28 mg (equivalent: tenofovir alafenamide, qty 25 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - treatment of hiv-1 infection: descovy is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25kg. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of descovy (see section 5.1 pharmacodynamic properties).,hiv-1 pre-exposure prophylaxis: descovy is indicated for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

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.