United States - English - NLM (National Library of Medicine)

physicians total care, inc. - estropipate (unii: svi38uy019) (estropipate - unii:svi38uy019) - estropipate 0.75 mg - estropipate tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. treatment of moderate to severe vasomotor symptoms associated with the menopause. - treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be con

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - estropipate (unii: svi38uy019) (estrone - unii:2di9ha706a) - estropipate 1.5 mg - estropipate tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. treatment of moderate to severe vasomotor symptoms associated with the menopause. - treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - taipan antivenom, quantity: 12000 u - injection, concentrated - excipient ingredients: sodium chloride; phenol; water for injections - for the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a taipan.

United States - English - NLM (National Library of Medicine)

avera mckennan hospital - estropipate (unii: svi38uy019) (estrone - unii:2di9ha706a) - estropipate 1.5 mg

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

Australia - English - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - sebelipase alfa, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; albumin - kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase deficiency (lal-d).

United States - English - NLM (National Library of Medicine)

alexion pharmaceuticals, inc. - sebelipase alfa (unii: k4ytu42t8g) (sebelipase alfa - unii:k4ytu42t8g) - sebelipase alfa 2 mg in 1 ml - kanuma® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase (lal) deficiency. none. risk summary available data with kanuma use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproductive studies conducted with sebelipase alfa showed no evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at dosages up to 164 and 526 times the human dosage of 1 mg/kg every other week (based on auc) in rats and rabbits, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. animal data sebelipase alfa administered during the period of organogenesis to rats (on gestation days 6, 9, 12, 15 and 17) and rabbits

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bayer cropscience pty ltd - benzofenap - suspension concentrate - benzofenap ungrouped active 300.0 g/l - herbicide - rice | combine sown - alisma seedling | arrowhead | dirty dora or variable flat sedge | starfruit - seedling | water plantain - seedling | arrow head | star fruit

Australia - English - Department of Health (Therapeutic Goods Administration)

taipan antivenom -

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).