Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 5 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 10 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 2.5 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

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

australia natural health pharmaceutical - borax,calcium citrate,cholecalciferol,equisetum arvense,hydroxyapatite,magnesium oxide - heavy,manganese amino acid chelate,phytomenadione,zinc gluconate -

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - danazol 100mg - capsule - 100 mg - active: danazol 100mg excipient: colloidal silicon dioxide gelatin   iron oxide black   lactose lactose monohydrate magnesium stearate microcrystalline cellulose povidone sodium laurilsulfate sodium starch glycolate tekprint black sw-9008 titanium dioxide   - endometriosis: danazol is indicated for use in the treatment of endometriosis amenable to hormonal management. menorrhagia: danazol is indicated for the short-term (up to 6 months) management of primary menorrhagia. fibrocystic disease of the breast: danazol is indicated for the treatment of fibrocystic disease of the breast in both pre- and post-menopausal women. hereditary angioedema: danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - danazol 200mg - capsule - 200 mg - active: danazol 200mg excipient: colloidal silicon dioxide erythrosine gelatin   iron oxide red iron oxide yellow lactose lactose monohydrate magnesium stearate microcrystalline cellulose povidone sodium laurilsulfate sodium starch glycolate tekprint black sw-9008 titanium dioxide   - endometriosis: danazol is indicated for use in the treatment of endometriosis amenable to hormonal management. menorrhagia: danazol is indicated for the short-term (up to 6 months) management of primary menorrhagia. fibrocystic disease of the breast: danazol is indicated for the treatment of fibrocystic disease of the breast in both pre- and post-menopausal women. hereditary angioedema: danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

bgp products ltd - dydrogesterone - film coated tablet - 10 milligram - pregnadien derivatives - urinary system and sex hormones - in the management of conditions associated with progesterone insufficiency: dysmenorrhoea, endometriosis, infertility, irregular menstrual cycles and pre-menstrual syndrome. the drug may be used with an estrogen in the management of dysfunctional bleeding or secondary amenorrhoea, or in association with estrogen in hormone replacement therapy.

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

alphapharm pty ltd - danazol -

Israel - English - Ministry of Health

sanofi - aventis israel ltd - valproic acid; valproic acid as sodium - tablets prolonged release - valproic acid 145 mg; valproic acid as sodium 333 mg - valproic acid - treatment of generalized or partial epilepsy secondary epilepsy and mixed forms of epilepsy. bipolar disorders: treatment and/or prevention of acute manic episodes in the context of bipolar disorders.

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

northstar rx llc - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 1 mg - dasetta™ 1/35 tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant® system depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from hatcher et al, 1998, ref. #1. emergency contraceptive pills: treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactational amenorrhea method: lam is highly effective, temporary method of contraception.1 0 source: trussell j, contraceptive efficacy. in hatcher ra, trussell j, stewart f, cates w, stewart gk, kowal d, guest f, contraceptive technology: seventeenth revised edition. new york ny: irvington publishers, 1998. 1 among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 foams, creams, gels, vaginal suppositories, and vaginal film. 6 cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 with spermicidal cream or jelly. 8 without spermicides. 9 the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the food and drug administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: ovral® (1 dose is 2 white pills), alesse® (1 dose is 5 pink pills), nordette® or levlen® (1 dose is 2 light-orange pills), lo/ovral® (1 dose is 4 white pills), triphasil® or tri-levlen® (1 dose is 4 yellow pills). 1 0 however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. dasetta ™ 1/35 has not been studied for and is not indicated for use in emergency contraception. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - known thrombophilic conditions - cerebral vascular or coronary artery disease (current or history) - valvular heart disease with complications - persistent blood pressure values of 160 mm hg systolic or 100 mg hg diastolic96 - diabetes with vascular involvement - headaches with focal neurological symptoms - major surgery with prolonged immobilization - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy or jaundice with prior pill use - acute or chronic hepatocellular disease with abnormal liver function - hepatic adenomas or carcinomas - known or suspected pregnancy - hypersensitivity to any component of this product - are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment)