United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - descovy is indicated, in combination with other antiretroviral agents, for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg. descovy is indicated, in combination with other antiretroviral agents other than protease inhibitors that require a cyp3a inhibitor, for the treatment of hiv-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg. descovy is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of hiv-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. individuals must have a negative hiv-1 test immediately prior to initiating descovy for hiv-1 prep [see dosage and administration (2.2) and warnings and precautions (5.2)]. limitations of use: the indication does not include use of descovy in individuals at risk of hiv-1 from receptive vaginal sex because effectiveness in this population has not been evaluated [see clinical studies

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - idelalisib (unii: yg57i8t5m0) (idelalisib - unii:yg57i8t5m0) - idelalisib 100 mg - zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (cll) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. limitations of use zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with cll, small lymphocytic lymphoma (sll), follicular lymphoma (fl), and other indolent non-hodgkin lymphomas. zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with fl, sll, and other indolent non-hodgkin lymphomas. zydelig is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or patients with a history of toxic epidermal necrolysis with any drug [see warnings and precautions (5.6, 5.7)] . risk summary based on findings in animal studies and the mechanism of action [see clinical pharmac

United States - English - NLM (National Library of Medicine)

gilead sciences, inc - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan 5 mg - letairis is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - to improve exercise ability and delay clinical worsening. - in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening pah, and to improve exercise ability [see clinical studies (14.2)]. studies establishing effectiveness included predominantly patients with who functional class ii–iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). letairis may cause fetal harm when administered to a pregnant female. letairis is contraindicated in females who are pregnant. letairis was consistently shown to have teratogenic effects when administered to animals. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precau

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; indigo carmine; hypromellose; triacetin - viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,viread is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,viread is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation. viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults. viread is indicated for the treatment of chronic hepatitis b in adults with evidence of active viral replication and active liver inflammation.

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.

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg - capsule, hard - excipient ingredients: crospovidone; povidone; microcrystalline cellulose; magnesium stearate; propylene glycol; purified water; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; indigo carmine; potable water; gelatin; sodium lauryl sulfate - emtriva is indicated for the treatment of hiv in combination with other antiretroviral agents in adults and paediatric patients 12 years of age and older, weighing more than 33 kg. evidence to support this claim is based on surrogate markers (plasma hiv rna and cd4 count) in antiretroviral naive individuals and in antiretroviral experienced individuals with virological suppression (see clinical trials).

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg - capsule, hard - excipient ingredients: magnesium stearate; microcrystalline cellulose; povidone; crospovidone; titanium dioxide; indigo carmine; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; purified water; ethanol; strong ammonia solution; potassium hydroxide; iron oxide black - emtriva is indicated for the treatment of hiv in combination with other antiretroviral agents in adults and paediatric patients 12 years of age and older, weighing more than 33 kg. evidence to support this claim is based on surrogate markers (plasma hiv rna and cd4 count) in antiretroviral naive individuals and in antiretroviral experienced individuals with virological suppression (see clinical trials).

United States - English - NLM (National Library of Medicine)

gilead sciences, inc - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - truvada is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older [see clinical studies (14)] . truvada is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating truvada for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)] . truvada for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to truvada during pregnancy. healthcare providers are encouraged to register patients on the worldwide antiretroviral pregnancy registry (apr) at http://www.apregistry.com/. risk summary data on the use of truvada during pregnancy from

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women