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(Approval lapsed) Estraderm MX 100 estradiol 100microgram/24hours transdermal delivery system sachet (Norgine UK)

Section 19A approved medicine
(Approval lapsed) Estraderm MX 100 estradiol 100microgram/24hours transdermal delivery system sachet (Norgine UK)
Section 19A approval holder
Juno Pharmaceuticals Pty Ltd ABN 55 156 303 650
Phone
03 8888 1288
Approved until
Status
Expired
Medicines in short supply/unavailable
ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system sachet - ARTG 97566
ESTRADERM MX 100 estradiol 100 microgram/24 hours (3mg) transdermal drug delivery system sachet - ARTG 67090
Indication(s)

Menopausal symptoms:Short-term treatment of signs and symptoms of estrogen deficiency due to the menopause, whether natural or surgically induced. In women with intact uteri, estrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

Prevention of post-menopausal bone mineral density loss: Estraderm MX 50, 75 and 100 may be used for prevention of postmenopausal 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-estrogen products approved for prevention of bone mineral density loss. Lifestyle modifications and the riskbenefit 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.

Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

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