Kenya - English - Pharmacy and Poisons Board

ledispavir acetone solvate/ sofosbuvir - film-coated tablet - ledispavir acetone solvate 90mg, sofosbuvir 300mg - sofosbuvir and ledipasvir

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - hepatitis c, chronic - antivirals for systemic use - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).for hepatitis c virus (hcv) genotype-specific activity see sections 4.4 and 5.1.

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).

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

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

unimed sdn bhd - ledipasvir; sofosbuvir -

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.

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

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

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