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

asegua therapeutics llc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) [see dosage and administration (2.2 and 2.3) and clinical studies (14)]: - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin if ledipasvir and sofosbuvir is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2)] . risk summary if ledipasvir and sofosbuvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin

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, - ledipasvir/ sofosbuvir - tablet - each tablet contains: ledipasvir/ sofosbuvir 90… - sofosbuvir and ledipasvir

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)

unimed sdn bhd - ledipasvir; sofosbuvir -

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

gilead sciences, inc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir 90 mg - harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) [see dosage and administration (2.2 and 2.3) and clinical studies (14)] : - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin if harvoni is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2)] . risk summary if harvoni 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 ribav

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

gilead sciences, inc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir 90 mg - adult patients : harvoni is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) [see dosage and administration (2.2) and clinical studies (14)] : - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin pediatric patients : harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with hcv genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis [see dosage and administration (2.3) and clinical studies (14.6)] . if harvoni is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and ad

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.

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.

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.