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.

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية بيتا - beta drug store - sofosbuvir 400 mg, ledipasvir 90 mg - 400 mg, 90 mg

Kenya - English - Pharmacy and Poisons Board

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

Kenya - English - Pharmacy and Poisons Board

gilead sciences, inc. 333 lakeside dr, foster city, ca 94404, usa - ledipasvir/sofosbuvir - film-coated tablet - 90 mg / 400mg - sofosbuvir and ledipasvir

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)

unimed sdn bhd - ledipasvir; sofosbuvir -

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - ledipasvir 90mg;  ;  ; sofosbuvir 400mg;  ;  ;   - film coated tablet - 90mg/400mg - active: ledipasvir 90mg     sofosbuvir 400mg       excipient: colloidal silicon dioxide copovidone croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry orange 85f13912 - harvoni is indicated for the treatment of chronic hepatitis c (chc) infection in adults and in pediatric patients 12 years of age and older or weighing at least 35 kg with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis.

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

gilead sciences international ltd - ledipasvir; sofosbuvir - tablet - 90mg ; 400mg

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - ledipasvir; sofosbuvir - tablet, film coated - ledipasvir 90 mg; sofosbuvir 400 mg