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.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - darunavir - film coated tablet - 400 milligram - protease inhibitors