USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol and 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, topical vaginal products should be considered. 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 and norethindrone acetate tablets are contraindicated in women with any of the following conditions: risk summary estradiol and norethindrone acetate tablets are not indicated for use in pregnancy. there are no data with the use of estradiol and norethindrone acetate tablets in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalities and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen

USA - engelsk - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol and 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 and 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 a

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - estradiol acetate (unii: 5r97f5h93p) (estradiol - unii:4ti98z838e) - estradiol acetate 0.1 mg in 24 [usp'u] - femring therapy is indicated in the: 1. treatment of moderate to severe vasomotor symptoms due to menopause. 2. treatment of moderate to severe vulvar and vaginal atrophy due to menopause. femring should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

USA - engelsk - 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

USA - engelsk - 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

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

viatris sante - estradiol 1; acétate de nomégestrol 2 - comprimé - blanc pour un comprimé > estradiol 1,5 mg sous forme de : estradiol hémihydraté > acétate de nomégestrol 2,5 mg comprimé placebo vert > pas de substance active. - hormones sexuelles et modulateurs de la fonction génitale - classe pharmacothérapeutique : hormones sexuelles et modulateurs de la fonction génitale, progestatifs et estrogènes en associations fixes, code atc : g03aa14 nomegestrol acetate/estradiol viatris 2,5 mg/1,5 mg, comprimé pelliculé est une pilule contraceptive utilisée pour éviter une grossesse. les 24 comprimés pelliculés blancs sont tous des comprimés actifs contenant deux hormones féminines différentes en faibles quantités. il s’agit du nomégestrol acétate (un progestatif) et de l’estradiol (un estrogène). les 4 comprimés verts sont des comprimés inactifs qui ne contiennent aucune hormone et sont appelés des comprimés placebo. les comprimés contraceptifs contenant deux hormones différentes, comme nomegestrol acetate/estradiol viatris 2,5 mg/1,5 mg, comprimé pelliculé, sont appelés « pilules combinées ». le nomégestrol acétate (le progestatif contenu dans ce médicament) et l’estradiol (l’estrogène contenu dans ce médicament) agissent ensemble pour empêcher l’ovulation (libération d’un ovule de l’ovaire) et pour réduire la probabilité qu’un ovule libéré soit fécondé et que vous tombiez enceinte.

USA - engelsk - NLM (National Library of Medicine)

allergan, inc. - estradiol acetate (unii: 5r97f5h93p) (estradiol - unii:4ti98z838e) - estradiol 0.05 mg in 1 d - femring is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding - known, suspected, or history of breast cancer - known or suspected estrogen-dependent neoplasia - active dvt, pe, or history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema to femring - known liver impairment or disease  - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy  femring should not be used during pregnancy [ see   contraindications (4) ] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. femring should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectabl

Australia - engelsk - 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 - engelsk - 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.

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

aspen pharma pty ltd - cyproterone acetate,ethinylestradiol -