Namibia - English - Namibia Medicines Regulatory Council

jansen pharmaceuticals - estradiol, estradiol hemihydrate , norethisterone acetate - tds - transdermal delivery system, estradiol, estradiol hemihydrate & norethisterone acetate

Ireland - English - HPRA (Health Products Regulatory Authority)

novo nordisk a/s - estradiol anhydrous; norethisterone acetate - film-coated tablet - 1 mg / 0.5 milligram(s) - progestogens and estrogens, fixed combinations; norethisterone and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

novo nordisk a/s - estradiol; norethisterone acetate; estradiol - film-coated tablet - %v/v - progestogens and estrogens, fixed combinations; norethisterone and estrogen

New Zealand - English - 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

New Zealand - English - 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.

New Zealand - English - 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.

Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate; norethisterone acetate - film coated tablets - estradiol as hemihydrate 1 mg; norethisterone acetate 1 mg - estradiol, combinations - estradiol, combinations - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women with an intact uterus. prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of , or contraindicated for other medicinal products approved for the prevention of osteoporosis.the experience treating women older than 65 years is limited.

Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate; norethisterone acetate - film coated tablets - estradiol as hemihydrate 0.5 mg; norethisterone acetate 0.1 mg - estradiol, combinations - estradiol, combinations - eviana is indicated for 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 experience treating women older than 65 years is limited .

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - estradiol (as hemihydrate) micronized; norethisterone acetate micronized - tablet, film coated - 1 mg - estradiol (as hemihydrate) micronized 1 mg; norethisterone acetate micronized 0.5 mg

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

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