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

viatris pty ltd - estradiol, quantity: 1 mg (equivalent: estradiol hemihydrate, qty 1.03 mg); dydrogesterone, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; hypromellose; maize starch; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uteri. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest possible effective dose for the shortest duration should be used with the goal being short term use.,hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use (see dosage and administration and clinical trials). when prescribed solely for the prevention of postmenopausal bone mineral density loss in women, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of femoston should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( see precautions and dosage and administration).

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - estradiol hemihydrate; dydrogesterone - film-coated tablet - 1/10 milligram(s) - progestogens and estrogens, sequential preparations; dydrogesterone and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - estradiol hemihydrate; dydrogesterone - film-coated tablet - 2/10 milligram(s) - progestogens and estrogens, sequential preparations; dydrogesterone and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

bgp products ltd - estradiol hemihydrate, dydrogesterone - film coated tablet - 2 mg, 10 m milligram - progestogens and estrogens, sequential preparations - sequential hormone replacement therapy - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women at least 6 months since the last menses. prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Ireland - English - HPRA (Health Products Regulatory Authority)

abbott healthcare products ltd - estradiol hemihydrate dydrogesterone - film coated tablet - 2 mg, 10 m milligram

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

orifarm - estradiol hemihydrate; dydrogesterone - film-coated tablet - 1 mg - 5 mg - estradiol hemihydrate; dydrogesterone 5 mg - dydrogesterone and estrogen

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

viatris pty ltd - dydrogesterone, quantity: 10 mg; estradiol, quantity: 2 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; lactose monohydrate; maize starch; titanium dioxide; iron oxide yellow; purified talc; macrogol 400 - hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use (see dosage and administration and clinical trials). when prescribed solely for the prevention of postmenopausal bone mineral density loss in women, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of femoston should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( see precautions and dosage and administration).

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

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg is also in

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

breckenridge pharmaceutical, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets are indicated for:   limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol/norethindrone acetate tablets are contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precauti

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

teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol vaginal inserts is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)]. - breast cancer or a history of breast cancer [see warnings and precautions (5.3)]. - estrogen-dependent neoplasia [see warnings and precautions (5.3)]. - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)]. - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)]. - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol vaginal inserts [see warnings and precautions (5.16)]. - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol vaginal inserts are not indicated for use in pregnancy. there are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have