Israel - English - Ministry of Health

gilead sciences israel ltd - sofosbuvir; velpatasvir; voxilaprevir - film coated tablets - voxilaprevir 100 mg; velpatasvir 100 mg; sofosbuvir 400 mg - sofosbuvir, velpatasvir and voxilaprevir - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, chronic - antivirals for systemic use - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).

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

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b), velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), voxilaprevir (unii: 0570f37359) (voxilaprevir - unii:0570f37359) - sofosbuvir 400 mg - vosevi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection without cirrhosis or with compensated cirrhosis (child-pugh a) who have [see dosage and administration (2.2) and clinical studies (14)]: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an ns5a inhibitor. - genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an ns5a inhibitor. additional benefit of vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an ns5a inhibitor. - additional benefit of vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an ns5a inhibitor. vosevi is contraindicated with rifampin [see drug interactions (7.3), and clinical pharmacology (12.3)]. risk summary no adequate human data are available to establish whether or not vosevi poses a risk to pregnancy outcomes. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of vosevi (sofosbuvir, velpatasvir, or voxilaprevir) at exposures greater than those in humans at the recommended human dose (rhd) [see data] . during organogenesis in the mouse, rat, and rabbit, systemic exposures (auc) of velpatasvir were approximately 23 (mice), 4 (rats), and 0.5 (rabbits) times the exposure in humans at the rhd, while exposures of voxilaprevir were approximately 141 (rats) and 4 (rabbits) times the exposure in humans at the rhd. exposures of the predominant circulating metabolite of sofosbuvir (gs-331007) were approximately 6 (rats) and 16 (rabbits) times the exposure in humans at the rhd. in rat pre/postnatal development studies, maternal systemic exposures (auc) for each component of vosevi were approximately 7 (sofosbuvir metabolite gs-331007), 3 (velpatasvir), and 238 (voxilaprevir) times the exposure in humans at the rhd. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data sofosbuvir: sofosbuvir was administered orally to pregnant rats (up to 500 mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to 19, respectively, and also to rats (oral doses up to 500 mg/kg/day) from gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of the predominant circulating metabolite of sofosbuvir (gs-331007) during gestation were approximately 6 (rats) and 16 (rabbits) times the exposure in humans at the rhd. velpatasvir: velpatasvir was administered orally to pregnant mice (up to 1000 mg/kg/day), rats (up to 200 mg/kg/day) and rabbits (up to 300 mg/kg/day) from gestation days 6 to 15, 6 to 17, and 7 to 20, respectively, and also to rats (oral doses up to 200 mg/kg) on gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (mice, rats, and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of velpatasvir during gestation were approximately 23 (mice), 4 (rats), and 0.5 (rabbits) times the exposure in humans at the rhd. voxilaprevir: voxilaprevir was administered orally to pregnant rats (up to 100 mg/kg/day) and rabbits (up to 600 mg/kg/day) from gestation days 6 to 17, and 7 to 19, respectively, and also to rats (oral doses up to 100 mg/kg) on gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of voxilaprevir during gestation were approximately 141 (rats) and 4 (rabbits) times the exposure in humans at the rhd. risk summary it is not known whether the components of vosevi and its metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant. when the components of vosevi were administered to lactating rats, gs-331007 (the predominant circulating metabolite of sofosbuvir) and velpatasvir were detected in milk, while voxilaprevir was detected in the plasma of nursing pups likely due to the presence of voxilaprevir in milk. no significant effects of any of the drugs were observed in nursing rat pups [see data]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vosevi and any potential adverse effects on the breastfed child from vosevi or from the underlying maternal condition. data sofosbuvir: no significant effects of sofosbuvir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of the predominant circulating metabolite of sofosbuvir (gs-331007) was approximately 7 times the exposure in humans at the rhd, with exposure of approximately 2% that of maternal exposure observed in nursing pups on lactation day 10. in a lactation study, sofosbuvir metabolites (primarily gs-331007) were excreted into the milk of lactating rats following administration of a single oral dose of sofosbuvir (20 mg/kg) on lactation day 2, with milk concentrations of approximately 10% that of maternal plasma concentrations observed 1 hour post-dose. velpatasvir: no significant effects of velpatasvir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of velpatasvir was approximately 3 times the exposure in humans at the rhd. velpatasvir was present in the milk (approximately 173% that of maternal plasma concentrations) of lactating rats following a single oral dose of velpatasvir (30 mg/kg), and systemic exposure (auc) in nursing pups was approximately 4% that of maternal exposure on lactation day 10. voxilaprevir: no significant effects of voxilaprevir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of voxilaprevir was approximately 238 times the exposure in humans at the rhd, with exposure of approximately 58% that of maternal exposure observed in nursing pups on lactation day 10. safety and effectiveness of vosevi have not been established in pediatric patients. clinical trials of vosevi included 74 subjects aged 65 and over (17% of total number of subjects in the polaris-1 and polaris-4 phase 3 clinical trials). no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment of vosevi is warranted in geriatric patients [see clinical pharmacology (12.3)]. no dosage adjustment of vosevi is recommended for patients with mild, moderate, or severe renal impairment, including esrd requiring dialysis [see dosage and administration (2.3) and clinical pharmacology (12.3)]. no dosage adjustment of vosevi is recommended for patients with mild hepatic impairment (child-pugh a). vosevi is not recommended in patients with moderate or severe hepatic impairment (child-pugh b or c) due to the higher exposures of voxilaprevir (up to 6-fold in non-hcv infected subjects); the safety and efficacy have not been established in hcv-infected patients with moderate or severe hepatic impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. postmarketing cases of hepatic decompensation/failure have been reported in these patients [see warnings and precautions (5.2)].

Canada - English - Health Canada

gilead sciences canada inc - sofosbuvir; velpatasvir; voxilaprevir - tablet - 400mg; 100mg; 100mg - sofosbuvir 400mg; velpatasvir 100mg; voxilaprevir 100mg - hcv polymerase inhibitors

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

gilead sciences pty ltd - voxilaprevir, quantity: 100 mg; velpatasvir, quantity: 100 mg; sofosbuvir, quantity: 400 mg - tablet - excipient ingredients: lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - vosevi (sofosbuvir/velpatasvir/voxilaprevir fixed-dose combination) is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an ns5a inhibitor; - genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an ns5a inhibitor; (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties, clinical trials).

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - sofosbuvir; velpatasvir; voxilaprevir - tablet, film coated - sofosbuvir 400 mg; velpatasvir 100 mg; voxilaprevir 100 mg

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

gilead sciences pty ltd - sofosbuvir, quantity: 400 mg; ledipasvir acetone solvate, quantity: 95.9 mg (equivalent: ledipasvir, qty 90 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - harvoni (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis c (chc) infection in adults. (see precautions and clinical trials sections for information on the available data for hcv patients of each genotype, see dosage and administration section for recommended regimens and treatment durations for different patient subgroups).

Kenya - English - Pharmacy and Poisons Board

mylan laboratories limited mylan laboratories limited plot no.564/a/22, road - sofosbuvir - film-coated tablet - each film coated tablets contains: sofosbuvir 400… - sofosbuvir

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

gilead sciences international ltd - voxilaprevir; velpatasvir; sofosbuvir - tablet - 100mg ; 100mg ; 400mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

gilead sciences ireland uc, ireland - sofosbuvir,velpatasvir,voxilaprevir - film-coated tablet - 400,100,100 mg,