Israel - English - Ministry of Health

abic marketing ltd, israel - deutetrabenazine - tablets extended release - deutetrabenazine 6 mg - austedo is indicated in adults for the treatment of: • chorea associated with huntington’s disease • tardive dyskinesia

Israel - English - Ministry of Health

abic marketing ltd, israel - deutetrabenazine - tablets extended release - deutetrabenazine 9 mg - austedo is indicated in adults for the treatment of: • chorea associated with huntington’s disease • tardive dyskinesia

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

janssen-cilag pty ltd - darunavir -

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - darunavir ethanolate 325.23mg equivalent to darunavir 300 mg - film coated tablet - 300 mg - active: darunavir ethanolate 325.23mg equivalent to darunavir 300 mg excipient: crospovidone magnesium stearate opadry orange 85f13962 purified water silicified microcrystalline cellulose - adult patients: prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.

European Union - English - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - acute coronary syndrome - antithrombotic agents - angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (pci), including patients with st-segment-elevation myocardial infarction (stemi) undergoing primary pci.angiox is also indicated for the treatment of adult patients with unstable angina / non-st-segment-elevation myocardial infarction (ua / nstemi) planned for urgent or early intervention.angiox should be administered with aspirin and clopidogrel.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - darunavir ethanolate 867.28mg equivalent to darunavir 800 mg - film coated tablet - 800 mg - active: darunavir ethanolate 867.28mg equivalent to darunavir 800 mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate opadry red 85f150004 purified water silicified microcrystalline cellulose - adult patients: prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 400 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 600 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

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.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 150 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.