Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

bayer new zealand limited - norethisterone 5mg;   - tablet - 5 mg - active: norethisterone 5mg   excipient: lactose monohydrate magnesium stearate maize starch

Singapore - inglese - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - norethisterone - tablet - 5 mg - norethisterone 5 mg

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

bayer australia ltd - norethisterone, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; maize starch; magnesium stearate - dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, delay of menstrual period, endometriosis, adjunct to estrogen hormone replacement therapy.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

bayer limited - norethisterone - tablet - 5 milligram(s) - estren derivatives; norethisterone

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - estradiol hemihydrate 0.256mg equivalent to estradiol 25 µg/24 hours;  ; norethisterone acetate 2.4mg equivalent to norethisterone acetate 125 µg/24 hours;   - transdermal patch - 25/125 - active: estradiol hemihydrate 0.256mg equivalent to estradiol 25 µg/24 hours   norethisterone acetate 2.4mg equivalent to norethisterone acetate 125 µg/24 hours   excipient: acrylic adhesive dipropylene glycol oleic acid povidone silicone adhesive

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - estradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours;  ; norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours;   - transdermal patch - 50/140 - active: estradiol hemihydrate 0.62mg equivalent to oestradiol 50 µg/24 hours   norethisterone acetate 2.7mg equivalent to norethisterone acetate 140 µg/24 hours   excipient: acrylic adhesive dipropylene glycol oleic acid povidone silicone adhesive - treatment of symptoms of oestrogen deficiency in postmenopausal women with an intact uterus. prevention of osteoporosis in postmenopausal women with an intact uterus.

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - estradiol hemihydrate 0.512mg equivalent to oestradiol 50 µg/24 hours;  ; norethisterone acetate 4.8mg equivalent to norethisterone acetate 250 µg/24 hours;   - transdermal patch - 50/250 - active: estradiol hemihydrate 0.512mg equivalent to oestradiol 50 µg/24 hours   norethisterone acetate 4.8mg equivalent to norethisterone acetate 250 µg/24 hours   excipient: acrylic adhesive dipropylene glycol oleic acid povidone silicone adhesive - treatment of symptoms of oestrogen deficiency in postmenopausal women with an intact uterus. prevention of osteoporosis in postmenopausal women with an intact uterus.

Australia - inglese - 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.

Israele - inglese - 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.

Malta - inglese - 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