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

j m mcgill ltd - estradiol - oral tablet - 2mg

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal 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 estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

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.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novo nordisk pharma sa-nv - estradiol hemihydrate 1,03 mg - eq. estradiol 1 mg (white tablet); norethisterone acetate 1 mg (white tablet); estradiol hemihydrate 1,03 mg - eq. estradiol 1 mg (red tablet) - film-coated tablet - 1 mg + 1 mg - 1 mg - estradiol hemihydrate 1.03 mg; estradiol hemihydrate 1.03 mg; norethisterone acetate 1 mg - norethisterone and estrogen

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

theramex australia pty ltd - estradiol hemihydrate, quantity: 1 mg; progesterone, quantity: 100 mg - capsule, soft - excipient ingredients: mono- and di- glycerides; gelatin; glycerol; purified water; lauroyl macrogolglycerides; hydrolysed gelatin; allura red ac; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400 - bijuva 1/100 is indicated for use during continuous combined hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 1.64mg - transdermal patch - 100 mcg/24h - active: estradiol hemihydrate 1.64mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 0.41mg - transdermal patch - 25 mcg/24h - active: estradiol hemihydrate 0.41mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 0.82mg - transdermal patch - 50 mcg/24h - active: estradiol hemihydrate 0.82mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - estradiol hemihydrate 1.23mg - transdermal patch - 75 mcg/24h - active: estradiol hemihydrate 1.23mg excipient: acrylic adhesive dipropylene glycol oleyl alcohol pegoterate polyolefin povidone silicone adhesive - estradiol is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - estradiol hemihydrate 7.84mg equivalent to estradiol 7.59 mg (100 µg/24h) - transdermal patch - 100 mcg/24h - active: estradiol hemihydrate 7.84mg equivalent to estradiol 7.59 mg (100 µg/24h) excipient: acrylates copolymer ethyl oleate glyceryl monolaurate isopropyl myristate - for short-term treatment of complaints associated with the menopause and post-menopause, including signs and symptoms of oestrogen deficiency, whether naturally or surgically induced. oestrogen replacement therapy in women with an intact uterus should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals. prevention of postmenopausal osteoporosis.