Amerikas Savienotās Valstis - angļu - 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

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bayer healthcare, inc. - gadofosveset trisodium (unii: xm33q67uvh) (gadofosveset - unii:e65rw73phs) - injection - 244 mg in 1 ml - vasovist is indicated for use as a contrast agent in magnetic resonance angiography (mra) to evaluate aortoiliac occlusive disease (aiod) in adults with known or suspected peripheral vascular disease [see clinical studies (14) ]. history of a prior allergic reaction to a gadolinium-based contrast agent. pregnancy category c there are no adequate and well-controlled studies of vasovist in pregnant women. in animal studies, pregnant rabbits treated with gadofosveset trisodium at doses 3 times the human dose (based on body surface area) experienced higher rates of fetal loss and resorptions. because animal reproduction studies are not always predictive of human response, only use vasovist during pregnancy if the diagnostic benefit justifies the potential risks to the fetus. in reproductive studies, pregnant rats and rabbits received gadofosveset trisodium at various doses up to approximately 11 (rats) and 21.5 (rabbits) times the human dose (based on body surface area). the highest dose resulted in maternal t

Austrālija - angļu - 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).

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - sofosbuvir -

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - sofosbuvir -

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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

Kenija - angļu - 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