以色列 - 英文 - Ministry of Health

gilead sciences israel ltd - sofosbuvir - film coated tablets - sofosbuvir 400 mg - sofosbuvir - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.for hepatitis c virus (hcv) genotype specific activity, see physician leaflet .

以色列 - 英文 - Ministry of Health

gilead sciences israel ltd - sofosbuvir - film coated tablets - sofosbuvir 400 mg - sofosbuvir - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.for hepatitis c virus (hcv) genotype specific activity, see physician leaflet .

以色列 - 英文 - Ministry of Health

gilead sciences israel ltd - sofosbuvir; velpatasvir - film coated tablets - velpatasvir 100 mg; sofosbuvir 400 mg - sofosbuvir - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults.

以色列 - 英文 - Ministry of Health

gilead sciences israel ltd - sofosbuvir; velpatasvir - film coated tablets - velpatasvir 100 mg; sofosbuvir 400 mg - sofosbuvir - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults.

以色列 - 英文 - Ministry of Health

gilead sciences israel ltd - sofosbuvir; velpatasvir; voxilaprevir - film coated tablets - voxilaprevir 100 mg; velpatasvir 100 mg; sofosbuvir 400 mg - sofosbuvir, velpatasvir and voxilaprevir - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults.

马来西亚 - 英文 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mylan healthcare sdn. bhd. - velpatasvir; sofosbuvir -

马耳他 - 英文 - Medicines Authority

ge healthcare limited - tetrofosmin - solution for injection - tetrofosmin 230 µg - diagnostic radiopharmaceuticals

马耳他 - 英文 - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - tetrofosmin - kit for radiopharmaceutical preparation solution for injection - tetrofosmin 230 µg - diagnostic radiopharmaceuticals

美国 - 英文 - NLM (National Library of Medicine)

medi-physics inc. dba ge healthcare - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. myoview is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. none. risk summary there are no data with technetium tc99m tetrofosmin use in pregnant women to inform any drug associated risks. animal reproduction studies with technetium tc99m tetrofosmin have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary technetium tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). there are no data available regarding the effects of technetium tc99m tetrofosmin on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for myoview and any potential adverse effects on the breastfed child from myoview or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium tc99m tetrofosmin administration. safety and effectiveness in pediatric patients have not been established. of 2,300 subjects in clinical studies of myoview, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. no overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

马来西亚 - 英文 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - ledipasvir; sofosbuvir -