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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.03 mg (equivalent: estradiol, qty 1 mg); norethisterone acetate, quantity: 0.5 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; lactose monohydrate; purified talc; hypromellose; triacetin; magnesium stearate - short term treatment of menopausal symptoms related to oestrogen deficiency in women more than one year after menopause (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 profiles of kliovance 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.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - estradiol hemihydrate; norethisterone acetate - transdermal patch - 50 microg/24h +170 microgram(s)/24 hours - natural and semisynthetic estrogens, plain; estradiol, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

theramex ireland limited - estradiol hemihydrate; norethisterone acetate - transdermal patch - 50 microg/24h +170 microgram(s)/24 hours - natural and semisynthetic estrogens, plain; estradiol, combinations

Malta - English - Medicines Authority

novonordisk a/s novo alle, dk – 2880 bagsvaerd, denmark - norethisterone acetate, estradiol - film-coated tablet - norethisterone acetate 0.5 mg estradiol 1 mg - sex hormones and modulators of the genital system

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - estradiol hemihydrate, norethisterone acetate - transdermal patch - estradiol hemihydrate 3.2 milligram(s) ; norethisterone acetate 11.2 milligram(s) - sex hormones and modulators of the genital system

Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate; norethisterone as acetate - film coated tablets - estradiol as hemihydrate 1 mg; norethisterone as acetate 0.5 mg - norethisterone and estrogen - norethisterone and estrogen - hormone replacement therapy (hrt) for oestrogen deficiency symptoms in women more than one year after menopause. 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. the experience treating women older than 65 years is limited.

Ireland - English - HPRA (Health Products Regulatory Authority)

b & s healthcare - estradiol hemihydrate, norethisterone acetate - film coated tablet - 1/0.5 milligram - progestogens and estrogens, sequential preparations

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

sandoz pty ltd - norethisterone acetate, quantity: 4.8 mg (equivalent: estradiol hemihydrate, qty 0.806 mg; equivalent: norethisterone acetate, qty 250 microgram/24 h); estradiol, quantity: 0.512 mg (equivalent: estradiol, qty 50 microgram/24 h; equivalent: estradiol hemihydrate, qty 0.529 mg) - drug delivery system, transdermal - excipient ingredients: oleic acid; povidone; dipropylene glycol; 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. 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 hemihydrate, qty 0.806 mg; equivalent: norethisterone acetate, qty 140 microgram/24 h); estradiol, quantity: 0.62 mg (equivalent: estradiol, qty 50 microgram/24 h; equivalent: estradiol hemihydrate, qty 0.64 mg) - drug delivery system, transdermal - excipient ingredients: povidone; oleic acid; dipropylene glycol; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-n-(trimethylsilyl)silanamine; dimeticonol; ethyl acetate; ethanol; acrylates/va copolymer; polyethylene terephthalate; polyvinylidene flouride; ethylene/vinyl acetate copolymer - for the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. 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.