США - англійська - NLM (National Library of Medicine)

gilead sciences, inc. - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - velpatasvir 100 mg - epclusa™ is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. epclusa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if epclusa 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

Нова Зеландія - англійська - 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.

США - англійська - NLM (National Library of Medicine)

gilead sciences, inc. - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - velpatasvir 100 mg - epclusa is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. epclusa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if epclusa 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 ribavirin-associated risks of use during pregnancy. no adequate human data are available to establish whether or not epclusa poses a risk to pregnancy outcomes. in

Велика Британія - англійська - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

США - англійська - 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

США - англійська - 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

Велика Британія - англійська - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Намібія - англійська - Namibia Medicines Regulatory Council

hetero labs limited - sofosbuvir - tablet - each tablet contains sofosbuvir 400mg

Танзанія - англійська - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - daclatasvir dihydrochloride - film coated tablet - daclatasvir dihydrochloride equivalent to daclatasvir 60 mg and sofosbuvir 400 mg

Обʼєднані Арабські Емірати - англійська - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

10 glass ampoules (1ml) -