Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - daclatasvir dihydrochloride - film coated tablet - daclatasvir dihydrochloride equivalent to daclatasvir 60 mg and sofosbuvir 400 mg

Kenya - English - Pharmacy and Poisons Board

mylan laboratories limited mylan laboratories limited. plot no.564/a/22, - daclatasvir and sofosbuvir film-coated tablets 60… - film-coated tablet - each film-coated tablet contains: daclatasvir… - daclatasvir

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

bristol-myers squibb australia pty ltd - daclatasvir dihydrochloride -

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

bristol-myers squibb australia pty ltd - daclatasvir dihydrochloride -

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

gilead sciences pty ltd - velpatasvir, quantity: 100 mg; sofosbuvir, quantity: 400 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; copovidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide red; macrogol 4000; polyvinyl alcohol - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 dose and method of administration section for the recommended regimens for different patient subgroups).

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

e.r. squibb & sons, l.l.c. - daclatasvir dihydrochloride (unii: 50zo25c11d) (daclatasvir - unii:li2427f9ci) - daclatasvir 90 mg - daklinza is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis c virus (hcv) genotype 1 or genotype 3 infection [see dosage and administration (2) and clinical studies (14) ]. limitations of use: anticonvulsants phenytoin, carbamazepine may lead to loss of virologic response to daklinza antimycobacterial agents rifampin herbal products st. john’s wort (hypericum perforatum )                no adequate human data are available to determine whether or not daklinza poses a risk to pregnancy outcomes. in animal reproduction studies in rats and rabbits, no evidence of fetal harm was observed with oral administration of daclatasvir during organogenesis at doses that produced exposures up to 6 and 22 times, respectively, the recommended human dose (rhd) of 60 mg of daklinza. however, embryofetal toxicity was observed in rats and rabbits at maternally toxic doses that produced exposures of 33 and 98 times the human exposure, respectively, at the rhd of 6

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

mylan healthcare sdn. bhd. - velpatasvir; sofosbuvir -

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

synerrv sdn bhd - daclatasvir dihydrochloride -

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

synerrv sdn bhd - daclatasvir dihydrochloride -

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

asegua therapeutics llc - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. sofosbuvir and velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if sofosbuvir and velpatasvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy. no adequate human data are available to establish wheth