China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml: 80mg.
Approved Indications
- Prevention of Venous Thromboembolic Diseases: For medium to high-risk surgical procedures, particularly orthopedic or general surgery (including cancer surgery).
- Prevention in Mobility-Restricted Patients: For patients with acute diseases such as heart failure, respiratory failure, severe infections, or rheumatic diseases with an increased risk of venous thromboembolism.
- Treatment of Deep Vein Thrombosis and Pulmonary Embolism: Except for cases requiring thrombolytic therapy or surgery.
- Long-Term Treatment and Prevention: For patients with active cancer requiring long-term treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism.
- Extracorporeal Circulation: For use in hemodialysis to prevent thrombus formation.
- Combined Use with Aspirin: For unstable angina and non-ST segment elevation myocardial infarction, as well as acute ST segment elevation myocardial infarction, including patients requiring drug therapy or percutaneous coronary intervention (PCI).-Fineline Info & Tech
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