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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of oestrogen deficiency associated with natural or artificial menopause (see dosage and administration and clinical trials).

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

sandoz pty ltd - norethisterone acetate, quantity: 4.8 mg (equivalent: estradiol, qty 50 microgram; equivalent: norethisterone acetate, qty 250 microgram); estradiol, quantity: 0.512 mg (equivalent: estradiol, qty 50 microgram) - drug delivery system, transdermal - excipient ingredients: oleic acid; dipropylene glycol; povidone; polyethylene terephthalate; ethylene/vinyl acetate copolymer; polyvinylidene flouride; ethyl acetate; ethanol; toluene; acrylates/va copolymer; polytrimethylhydrosilylsiloxane; xylene; ammonia; 1,1,1-trimethyl-n-(trimethylsilyl)silanamine; dimeticonol - for the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. for prevention of postmenopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, 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 bone mineral density loss. lifestyle modifications and the risk-benefit profile of estalis continous should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing. combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

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

sandoz pty ltd - norethisterone acetate, quantity: 2.7 mg (equivalent: estradiol, qty 50 microgram; equivalent: norethisterone acetate, qty 140 microgram); estradiol, quantity: 0.62 mg (equivalent: estradiol, qty 50 microgram) - drug delivery system, transdermal - excipient ingredients: oleic acid; dipropylene glycol; povidone; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-n-(trimethylsilyl)silanamine; dimeticonol; polyethylene terephthalate; polyvinylidene flouride; ethyl acetate; ethanol; acrylates/va copolymer; ethylene/vinyl acetate copolymer - for the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. for prevention of postmenopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, 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 bone mineral density loss. lifestyle modifications and the risk-benefit profile of estalis continous should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing. combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

Ireland - English - HPRA (Health Products Regulatory Authority)

novo nordisk a/s - estradiol; estradiol; norethisterone acetate; estradiol - film-coated tablet - 2 2 1 1 mg/tablet - progestogens and estrogens, sequential preparations; norethisterone and estrogen

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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of postmenopausal oestrogen deficiency (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and 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 kliogest 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. kliogest is for use in postmenopausal women with an intact uterus. in perimenopausal women treated with kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.

Israel - English - Ministry of Health

j-c health care ltd - estradiol as hemihydrate; estradiol as hemihydrate; norethisterone acetate - patches - estradiol as hemihydrate 3.2 mg; norethisterone acetate 11.2 mg; estradiol as hemihydrate 3.2 mg - estradiol, combinations - estradiol, combinations - hormone replacement therapy for the relief of menopausal symptoms.

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 Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - estradiol; norethisterone acetate - oral tablet - 1mg ; 1mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novo nordisk ltd - estradiol; norethisterone acetate - oral tablet - 2mg ; 1mg