Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 75 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Canada - English - Health Canada

apotex inc - abacavir (abacavir sulfate); lamivudine; zidovudine - tablet - 300mg; 150mg; 300mg - abacavir (abacavir sulfate) 300mg; lamivudine 150mg; zidovudine 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

Canada - English - Health Canada

janssen inc - darunavir (darunavir ethanolate); cobicistat; emtricitabine; tenofovir alafenamide (tenofovir alafenamide hemifumarate) - tablet - 800mg; 150mg; 200mg; 10mg - darunavir (darunavir ethanolate) 800mg; cobicistat 150mg; emtricitabine 200mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 10mg - antiretrovirals

Canada - English - Health Canada

apotex inc - nevirapine; zidovudine; lamivudine - tablet - 200mg; 300mg; 150mg - nevirapine 200mg; zidovudine 300mg; lamivudine 150mg - nonnucleoside reverse transcriptase inhibitors

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - elbasvir 50mg; grazoprevir 100mg - film coated tablet - 50mg/100mg - active: elbasvir 50mg grazoprevir 100mg excipient: carnauba wax colloidal silicon dioxide copovidone croscarmellose sodium d-alpha tocoferol hypromellose lactose monohydrate magnesium stearate mannitol microcrystalline cellulose opadry beige 39k170006 sodium chloride sodium laurilsulfate - zepatier is indicated for the treatment of chronic hepatitis c genotypes 1, 3, or 4 infection in adults.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - grazoprevir; elbasvir - tablet - 100mg ; 50mg

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - elbasvir; grazoprevir - tablets - elbasvir 50 mg; grazoprevir 100 mg - elbasvir and grazoprevir - zepatier is indicated for the treatment of chronic hepatitis c (chc) genotypes 1 or 4 infection in adults

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - elbasvir; grazoprevir - tablets - elbasvir 50 mg; grazoprevir 100 mg - elbasvir and grazoprevir - zepatier is indicated for the treatment of chronic hepatitis c (chc) genotypes 1 or 4 infection in adults

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - maraviroc - film coated tablets - maraviroc 300 mg - maraviroc - maraviroc - celsentri is a ccr5 co-receptor antagonist indicated for combination antiretroviral treatment of adults infected with only ccr5-tropic hiv-1.• in treatment-naïve subjects, more subjects treated with celsentri experienced virologic failure and developed lamivudine resistance compared to efavirenz.• tropism testing with a highly sensitive tropism assay is required for the appropriate use of celsentri.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - rifabutin - capsules - rifabutin 150 mg - rifabutin - rifabutin - for the treatment of chronic tuberculosis where there is evidence of acid fast bacteria resistant to rifampicin or to two other alternative drugs. for the treatment of infections caused by mac or other atypical mycobacteria where there is evidence of resistant bacteria as above. for the treatment of infections caused by mac or other atypical mycobacteria in aids patients in all cases not subject to the above restrictions. for prevention of mac infections in aids patients whose cd4 counts lower or eqval to 200/mm3