Stati Uniti - inglese - 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

Sudafrica - inglese - South African Health Products Regulatory Authority (SAHPRA)

gilead sciences south africa (pty) ltd - tablet - 50,0 mg/200,0 mg/25,0 mg - each tablet contains bictegravir sodium 50,0 mg; emtricitabine 200,0 mg; tenofovir alafenamide 25,0 mg

Sudafrica - inglese - South African Health Products Regulatory Authority (SAHPRA)

gilead sciences south africa (pty) ltd - tablet - 400,0 mg/100,0 mg - each tablet contains sofosbuvir 400,0 mg and velpatasvir 100,0 mg

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - elvitegravir 85mg;  ;  ;  ;   - film coated tablet - 85 mg - active: elvitegravir 85mg         excipient: croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 85f91203 sodium laurilsulfate - indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults and adolescents when co-administered with a ritonavir-boosted protease inhibitor and other antiretroviral therapy.

Stati Uniti - inglese - 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

Stati Uniti - inglese - 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

Israele - inglese - 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 - inglese - HSA (Health Sciences Authority)

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

Stati Uniti - inglese - 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 weighing at least 17 kg [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 by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary data on the use of truvada during pregnancy from observational s

Stati Uniti - inglese - 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