Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - estradiol; norethisterone acetate - oral tablet - 2mg ; 1mg

Irlanda - inglês - 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

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone acetate, quantity: 40 mg/ml - injection, suspension - excipient ingredients: hydrochloric acid; macrogol 3350; miripirium chloride; sodium chloride; sodium hydroxide - indications as at 17 november 2004: a.for intramuscular administration. when oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of depo-nisolone is indicated as follows: 1. endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. congenital adrenal hyperplasia. hypercalcaemia associated with cancer. non-suppurative thyroiditis. 2. rheumatic disorders. as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis. epicondylitis. synovitis of osteoarthritis. acute non-specific tenosynovitis. rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). acute gouty arthritis. psoriatic arthritis. ankylosing spondylitis. acute and subacute bursitis. 3. collagen diseases. during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus. acute rheumatic carditis. systemic dermatomyositis (polymyositis). 4. dermatological diseases. pemphigus. bullous dermatitis herpetiformis. severe erythema multiforme (stevens-johnson syndrome). severe seborrhoeic dermatitis. exfoliative dermatitis. severe psoriasis. mycosis fungoides. 5. allergic states. control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma. drug hypersensitivity reactions. contact dermatitis.urticarial transfusion reactions. atopic dermatitis. acute non-infectious laryngeal oedema (adrenaline is the drug of first choice). serum sickness. 6. ophthalmic diseases. severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus. sympathetic ophthalmia. iritis, iridocyclitis. anterior segment inflammation. chorioretinitis. allergic conjunctivitis. diffuse posterior uveitis. allergic corneal marginal ulcers. optic neuritis. keratitis. 7. gastrointestinal diseases. to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy). regional enteritis (systemic therapy). 8. respiratory diseases.symptomatic sarcoidosis. berylliosis. fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy. aspiration pneumonitis. loeffler's syndrome not manageable by other means. 9. haematological disorders. acquired (autoimmune) haemolytic anaemia. erythroblastopenia (rbc anaemia). secondary thrombocytopenia in adults. congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases. for palliative management of: leukaemias and lymphomas in adults. acute leukaemia in childhood. 11. oedematous states. to induce diuresis or remission of proteinuria in the nephrotic syndrome without uraemia of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous. tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy. trichinosis with neurological or myocardial involvement. b. for intra-articular or soft tissue administration depo-nisolone is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis. epicondylitis. rheumatoid arthritis. acute non-specific tenosynovitis. acute and subacute bursitis. post-traumatic osteoarthritis. acute gouty arthritis. c. for intralesional administration. depo-nisolone is indicated for intralesional use in the following conditions: keloids.discoid lupus erythematosus. necrobiosis lipoidica diabeticorum. alopecia areata. localised hypertrophic, infiltrated inflammatory lesions of licen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis). depo-nisolone may also be useful in cystic tumours of an aponeurosis or tendon (ganglia).

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone acetate, quantity: 40 mg/ml - injection, suspension - excipient ingredients: sodium hydroxide; sodium chloride; miripirium chloride; hydrochloric acid; macrogol 3350; water for injections - indications as at 9 november 1993: a. for intramuscular administration: when oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of depo-medrol is indicated as follows: 1. endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. congenital adrenal hyperplasia. hypercalcaemia associated with cancer. no

Israel - inglês - Ministry of Health

truemed ltd. - estradiol as hemihydrate; norethisterone acetate - patches - estradiol as hemihydrate 3.2 mg; norethisterone acetate 11.2 mg - estradiol, combinations - estradiol, combinations - hormone replacement therapy for the relief of menopausal symptoms.

Israel - inglês - 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 - inglês - 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 .

Cingapura - inglês - 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

Cingapura - inglês - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - (blue tablet) estradiol hemihydrate 2.07mg equivalent to; (red tablet) estradiol hemihydrate 1.03mg equivalent to; (white tablet) estradiol as hemihydrate 2.07mg equivalent to; (white tablet) norethisterone acetate - tablet, film coated - 2 mg - (blue tablet) estradiol hemihydrate 2.07mg equivalent to 2 mg; (red tablet) estradiol hemihydrate 1.03mg equivalent to 1 mg; (white tablet) estradiol as hemihydrate 2.07mg equivalent to 2 mg; (white tablet) norethisterone acetate 1 mg

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - yaz is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception - treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.