| Document Date: 2015-07-02 12:40:13
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Company Vasomotor Systems / Bayer HealthCare Pharmaceuticals Inc. / / Event FDA Phase / / Facility X complex / Laboratory Tests / / IndustryTerm topical vaginal products / continuous combination product / treatment of / MedicalCondition antithrombin deficiency / anaphylactic reaction / ovarian cancer / systemic lupus erythematosus / gallbladder disease / HIV / dementia / Hypocalcemia / headache / severe hypercalcemia / vascular thrombosis / Uterine Bleeding / arterial vascular disease / Nausea / probable dementia / chorea / hepatitis C / breast pain / Metastatic disease / gastrointestinal and abdominal pain / Hyponatremia / arterial thromboembolic disease / hypoparathyroidism / Hereditary Angioedema / ENDOMETRIAL CANCER / obesity / pulmonary embolism / hypersensitivity / Diarrhea / coronary heart disease / pre-existing hypertriglyceridemia / estrogen-induced hypocalcemia / porphyria / BREAST CANCER / Malignant Neoplasms / fungal infections / Adrenal insufficiency / asthma / hyperkalemia / abdominal pain / papilledema / CARDIOVASCULAR DISORDERS / hypertension / cancer / CHD / hepatic hemangiomas / Hypothyroidism / Active arterial thromboembolic disease / endometrial hyperplasia / Hypertriglyceridemia / Carcinogenesis / documented heart disease / PROBABLE DEMENTIA Estrogen Plus Progestin Therapy Cardiovascular Disorders / stroke / hereditary angioedema exogenous estrogens / migraine / thromboembolism / otosclerosis / cardiovascular disease / Endometriosis / proptosis / HCV / bone metastases / invasive breast cancers / severe hypertriglyceridemia / pain / invasive breast cancer / myocardial infarction / diabetes mellitus / deep vein thrombosis / systemic lupus / angioedema / pancreatitis / venous thromboembolism / Probable Dementia Estrogen-alone / thrombophilic disorders / Hypercalcemia / Endometriosis Endometriosis / epilepsy / reported endometrial cancer / diplopia / hypercholesterolemia / / MedicalTreatment hormone therapy / surgery / thyroid hormone replacement therapy / hysterectomy / estrogen therapy / / Movie CK / EL / / Organization Estrogen administration / DOSAGE AND ADMINISTRATION / FDA / Hypercalcemia Estrogen administration / Hypothyroidism Estrogen administration / / / Product itraconazole / DRSP/1 mg E2 Tablets / E2 Tablets / medroxyprogesterone acetate / Angeliq 0.25 mg DRSP/0.5 / clarithromycin / ANGELIQ / Angeliq 0.5 mg DRSP/1 / DRSP/0.5 mg E2 Tablets / estradiol / testosterone / DRSP/1 mg E2 tablet / ketoconazole / EL / DRSP/0.5 mg E2 tablet / CE / CYP3A4 / / ProvinceOrState Michigan / / Technology alpha / drug metabolism / WHIMS protocol / Geriatrics / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ANGELIQ safely and effectively. See full prescribing information for ANGELIQ. ANGELIQ (drospirenone and estradiol) t