Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga manufacturing berhad - daclatasvir dihydrochloride -

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - nevirapine - tablets - nevirapine 200 mg - nevirapine - nevirapine - for use in combination with other antiretroviral agents for the treatment of hiv-1 infection.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - darunavir - hiv infections - antivirals for systemic use - 400mg and 800 mg film-coated tabletsdarunavir krka d.d., 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 krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection in adult patients (see section 4.2).darunavir krka d.d. 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).600mg film-coated tabletsdarunavir krka d.d., 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 krka d.d. 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.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - daclatasvir dihydrochloride - hepatitis c, chronic - antivirals for systemic use - daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis c virus (hcv) infection in adults (see sections 4.2, 4.4 and 5.1). for hcv genotype specific activity, see sections 4.4 and 5.1.,

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

bristol-myers squibb pharmaceuticals ltd - daclatasvir dihydrochloride - tablet - 30mg

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

bristol-myers squibb pharmaceuticals ltd - daclatasvir dihydrochloride - tablet - 60mg

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

bristol-myers squibb pharmaceuticals ltd - daclatasvir dihydrochloride - tablet - 90mg

Canada - English - Health Canada

gilead sciences canada inc - emtricitabine; elvitegravir; tenofovir disoproxil fumarate; cobicistat - tablet - 200mg; 150mg; 300mg; 150mg - emtricitabine 200mg; elvitegravir 150mg; tenofovir disoproxil fumarate 300mg; cobicistat 150mg - hiv integrase inhibitors

Canada - English - Health Canada

gilead sciences canada inc - emtricitabine; elvitegravir; tenofovir alafenamide (tenofovir alafenamide hemifumarate); cobicistat - tablet - 200mg; 150mg; 10mg; 150mg - emtricitabine 200mg; elvitegravir 150mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 10mg; cobicistat 150mg - hiv integrase inhibitors

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - daclatasvir dihydrochloride -