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To: RxLink®

From: Novogyne Pharmaceuticals

Combipatch (estradiol/norethindrone acetate transdermal system) Announcement

December 2004

Re: Combipatch

Combipatch Packaging Change

Novogyne Pharmaceuticals, a joint venture between Novartis Pharmaceuticals Corporation and Noven Pharmaceuticals Inc. would like to inform you about a change in packaging for Combipatch,  effective immediately.



0.05/0.14 MG/DAY STRENGTH NDC #0078-0377-42

0.05/0.25 MG/DAY STRENGTH NDC #0078-0378-42

This package size replaces old package size of 3x8's:

NDC #0078-0377-45 Combipatch 0.05/0.14 mg/day

NDC #0078-0378-45 Combipatch 0.05/0.25 mg/day

For a short time, both package sizes, the new 1x8 and the original 3 boxes of 8 patches, will exist in the market. This is only a change in packaging, and returns of the 3 boxes of 8 patches are NOT necessary. Novartis Pharmaceuticals' normal return policy will still apply to the original Combipatch 3 boxes of 8 patches inventory. Therefore, please continue to dispense your current inventory of Combipatch until your supply is exhausted. You will not be reimbursed for any product returned outside of policy. Our policies are accessible on our Novartis Customer Connection website's public page. The URL is www.ncc.novartis.com.

Please see full Prescribing information enclosed.

If you have any questions regarding Combipatch, please call our Customer Service Department at 1-800-526-0175.

We appreciate your understanding and your continued support.

Regards, Jorge Lorenzo

Director of Marketing

Novogyne Pharmaceuticals



Estrogens and progestins should not be used for the prevention of cardiovascular disease.

The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women ( 50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate ( MPA 2.5 mg) relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased rick of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus MPA relative to placebo. It is unknown whether this finding applies to younger postmenopausal womne.

Other doses of oral conjugated estrogens with MPA, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual women.

Estrogens and estrogens/progestins combined should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In clinical trials, the most common side effects were breast pain, dysmenorrhea, and headache.

Combipatch ( estradiol/norethindrone acetate transdermal system) is indicated for women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, and moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When prescribing solely for the treatment of

symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.


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