Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - darunavir - film coated tablets - darunavir 800 mg - darunavir - darunavir teva co-administered with 100 mg ritonavir and with other antiretroviral agents,is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for patients over 18 years of age.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - darunavir - film coated tablets - darunavir 600 mg - darunavir - darunavir teva co-administered with 100 mg ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - darunavir - film-coated tablet - darunavir 400 mg - antivirals for systemic use

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - darunavir - film-coated tablet - darunavir 600 meq/ml - antivirals for systemic use

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - darunavir - film-coated tablet - 600 milligram(s) - protease inhibitors; darunavir

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals, inc. - darunavir hydrate (unii: kpc4nrb25l) (darunavir - unii:yo603y8113) - darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adult and pediatric patients 3 years of age and older [see use in specific populations (8.4) and clinical studies (14)]. co-administration of darunavir/ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see drug interactions (7.3)] . due to the need for co-administration of darunavir with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - alpha 1-adrenoreceptor antagonist: alfuzosin - anti-gout: colchicine, in patients with renal and/or hepatic impairment -

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infections - antivirals for systemic use - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4.2).darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):for the treatment of hiv-1 infection in antiretroviral treatment (art)-experienced adult patients, including those that have been highly pre-treated.for the treatment of hiv-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection. darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.2). art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. in deciding to initiate treatment with darunavir in such art-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 400mg; darunavir 400mg - film coated tablet - 400 mg - active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f530014 sodium starch glycolate active: darunavir 400mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (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. darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 600mg; darunavir 600mg - film coated tablet - 600 mg - active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 600mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir mylan (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. darunavir mylan (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

Kenya - English - Pharmacy and Poisons Board

laurus labs limited 2nd floor, serene chambers, road no.-7 banjara - darunavir - film-coated tablet - darunavir 400mg - darunavir