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

gedeon richter australia pty ltd - relugolix, quantity: 40 mg; estradiol, quantity: 1 mg (equivalent: estradiol hemihydrate, qty 1.032 mg); norethisterone acetate, quantity: 0.5 mg - tablet, film coated - excipient ingredients: mannitol; sodium starch glycollate type a; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow - ryeqo is indicated in adult women of reproductive age for:,? treatment of moderate to severe symptoms of uterine fibroids,,?symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1 pharmacodynamic properties).

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %);  ;  ;  ; norethisterone acetate 1mg;  ;  ;  ; estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); norethisterone acetate 1mg - film coated tablet - active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)       norethisterone acetate 1mg       excipient: hyprolose hypromellose lactose monohydrate magnesium stearate maize starch purified talc purified water triacetin active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) norethisterone acetate 1mg

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %);  ;  ;  ; norethisterone acetate 1mg;  ;  ;  ; estradiol hemihydrate 1.03mg (adjustment for water content 3.2%); estradiol hemihydrate 2.07mg (adjustment for water content 3.2%); estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); estradiol hemihydrate 1.03mg (adjustment for water content 3.2 %); estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); norethisterone acetate 1mg - film coated tablet - active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)       norethisterone acetate 1mg       excipient: hyprolose hypromellose lactose monohydrate magnesium stearate maize starch purified talc purified water triacetin active: estradiol hemihydrate 1.03mg (adjustment for water content 3.2%) excipient: hyprolose hypromellose iron oxide red as red paste, with titanium dioxide, hypromellose, talc and propylene glycol lactose monohydrate magnesium stearate maize starch propylene glycol purified talc   purified water titanium dioxide active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2%) excipient: hyprolose hypromellose indigo carmine lactose monohydrate macrogol 400 magnesium stearate maize starch purified talc   purified water titanium dioxide active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) estradiol hemihydrate 1.03mg (adjustment for water content 3.2 %) estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) norethisterone acetate 1mg - trisequens is indicated for the treatment of oestrogen deficiency syndrome, including prevention of bone mineral content loss in postmenopausal women at increased risk of developing fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (see also warnings and precautions)

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen-cilag ltd - norethisterone acetate ; estradiol hemihydrate - transdermal patch - 50/170 microgram - estradiol, combinations

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

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

impexeco - estradiol hemihydrate; norethisterone acetate - film-coated tablet - 1 mg - 0,5 mg - estradiol hemihydrate 1.03 mg; norethisterone acetate 0.5 mg - norethisterone and estrogen

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

novo nordisk pharma sa-nv - estradiol hemihydrate 2,07 mg - eq. estradiol 2 mg (blue tablet); estradiol hemihydrate 2,07 mg - eq. estradiol 2 mg (white tablet); norethisterone acetate 1 mg (white tablet); estradiol hemihydrate 1,03 mg - eq. estradiol 1 mg (red tablet) - film-coated tablet - 2 mg + 2 mg - 1 mg + 1 mg - estradiol hemihydrate 2.07 mg; norethisterone acetate 1 mg; estradiol hemihydrate 2.07 mg; estradiol hemihydrate 1.03 mg - norethisterone and estrogen

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

orifarm - estradiol hemihydrate; norethisterone acetate - film-coated tablet - 1 mg - 0,5 mg - estradiol hemihydrate; norethisterone acetate 0.5 mg - norethisterone and estrogen