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

gilead sciences pty ltd - lenacapavir sodium, quantity: 473.1 mg (equivalent: lenacapavir, qty 463.5 mg) - injection, solution - excipient ingredients: macrogol 300; water for injections - sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

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

gilead sciences pty ltd - lenacapavir sodium, quantity: 306.8 mg (equivalent: lenacapavir, qty 300 mg) - tablet, film coated - excipient ingredients: copovidone; poloxamer; mannitol; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

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. - 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

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - emtricitabine 200mg;  ;  ;  ; tenofovir disoproxil fumarate 300mg equivalent to tenofovir disoproxil 245 mg;  ;  ;   - tablet - 300mg/200mg - active: emtricitabine 200mg       tenofovir disoproxil fumarate 300mg equivalent to tenofovir disoproxil 245 mg       excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry blue y-30-10701 pregelatinised maize starch - truvada is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

Israel - English - Ministry of Health

gilead sciences israel ltd - amphotericin b - powder for concentrate for infusion - amphotericin b 50 mg/vial - amphotericin b - amphotericin b - antifungal antibiotic for the treatment of severe systemic and/or deep mycoses where toxicity precludes the use of conventional systemic amphotericin b in effective dosages. this drug should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests. ambisome is also indicated for the treatment of systemic fungal infections in immunocompromised patients (e.g. patients with aids or cancer). ambisome is also indicated for the primary therapy of visceral leishmaniasis in immunocompetent patients and immunocompromised patients (e.g. hiv positive). empirical treatment of presumed fungal infection in febrile neutropenic patients.

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - amphotericin b - injection, powder, for solution - 50 mg/vial - amphotericin b 50 mg/vial

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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

gilead sciences malaysia sdn. bhd. - sofosbuvir; velpatasvir -

Israel - English - Ministry of Health

gilead sciences israel ltd - aztreonam - lyophilized powder for nebuliser solution - aztreonam 75 mg/vial - aztreonam - cayston is indicated for the suppressive therapy of chronic pulmonary infections due to pseudomonas aeruginosa in patients with cystic fibrosis (cf) aged 6 years and older. consideration should be given to official guidance on the appropriate use of antibacterial agents.