Angeliq Regulatory Post Marketing Surveillance

Angeliq Regulatory Post Marketing Surveillance

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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