Israel - English - Ministry of Health

gilead sciences israel ltd - ledipasvir; sofosbuvir - film coated tablets - ledipasvir 90 mg; sofosbuvir 400 mg - sofosbuvir and ledipasvir - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adults.

Kenya - English - Pharmacy and Poisons Board

mylan laboratories limited mylan laboratories limited, plot no.564/a/22, - ledipasvir/ sofosbuvir - tablet - each tablet contains: ledipasvir/ sofosbuvir 90… - sofosbuvir and ledipasvir

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

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir 400 mg - adult patients: sovaldi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection as a component of a combination antiviral treatment regimen [see dosage and administration (2.2), and clinical studies (14)] - genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin - genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. pediatric patients: sovaldi is indicated for the treatment of chronic hcv genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see dosage and administration (2.3) and clinical studies (14.5)] . when sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. refer to the prescribing information of peginterfe

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

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir 400 mg - adult patients: sovaldi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection as a component of a combination antiviral treatment regimen [see dosage and administration (2.2), and clinical studies (14)] - genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin - genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. pediatric patients: sovaldi is indicated for the treatment of chronic hcv genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see dosage and administration (2.3) and clinical studies (14.5)] . when sovaldi is used in combination with ribavirin or peginterferon alfa/ribavi

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

gilead sciences malaysia sdn. bhd. - sofosbuvir; ledipasvir -

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

gilead sciences pty ltd - sofosbuvir -

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.

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).

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

gilead sciences, inc, usa - ledipasvir 90mg/sofosbuvir 400mg - tablets - ledipasvir 90 mg/ sofosbuvir 400 mg

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

synerrv sdn bhd - sofosbuvir -