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[Product Monograph Template - Standard]
product Monograph PrVagifem 10 Estradiol vaginal inserts USP, 10 g estradiol Vaginal inserts with applicators Estrogen Novo Nordisk Canada Inc. 300 2680 Skymark Ave. Mississauga, Ontario L4W 5L6 Date of Revision: 20 March 2017 Submission Control No: Level III Change Vagifem 10 (estradiol vaginal insertinsert USP) Page 2 of 36 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ..3 SUMMARY product INFORMATION ..3 INDICATIONS AND CLINICAL USE ..3 CONTRAINDICATIONS ..3 WARNINGS AND PRECAUTIONS ..4 ADVERSE REACTIONS ..11 DRUG INTERACTIONS ..14 DOSAGE AND ADMINISTRATION ..15 OVERDOSAGE ..15 ACTION AND CLINICAL PHARMACOLOGY ..16 STORAGE AND STABILITY ..18 DOSAGE FORMS, COMPOSITION AND PACKAGING ..18 PART II: SCIENTIFIC INFORMATION ..19 PHARMACEUTICAL INFORMATION ..19 CLINICAL TRIALS.
Vagifem® 10 (estradiol vaginal insert USP) Page 7 of 36 Ovarian Cancer: Recent epidemiologic studies have found the use of hormone therapy (estrogen-alone and estrogen plus progestin therapies), in particular for five or …
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