Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - darunavir propylene, glycolate - film-coated tablet - darunavir propylene glycolate 600 mg - antivirals for systemic use

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - darunavir - film-coated tablet - 600 milligram(s) - protease inhibitors; darunavir

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - darunavir - film-coated tablet - 75 milligram(s) - protease inhibitors; darunavir

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - darunavir - film-coated tablet - 400 milligram(s) - protease inhibitors; darunavir

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - darunavir - film-coated tablet - 800 milligram(s) - protease inhibitors; darunavir

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - darunavir - film-coated tablet - 800 milligram(s) - protease inhibitors; darunavir

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).