Angeliq regulatory Post Marketing Surveillance (Angeliq rPMS)
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.
- Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause - Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis
- Undiagnosed genital bleeding - Known, past or suspected cancer of the breast - Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer) - Untreated endometrial hyperplasia - Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism) - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) - Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal - Porphyria - Severe renal insufficiency or acute renal failure - Known hypersensitivity to the active substances or to any of the excipients
Many Locations, South Korea
E-mail: [email protected]
Phone: Not Available
Angeliq regulatory Post Marketing Surveillance