Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it has received marketing approval from the Thailand Food and Drug Administration (TFDA) for its enoxaparin sodium for injection.
The approved specifications include 0.2ml (20mg) and 0.4ml (40mg), indicated for the prevention of venous thromboembolic diseases, particularly venous thrombosis associated with orthopedic and general surgeries. Additionally, the 0.6ml (60mg) and 0.8ml (80mg) formulations are approved for several critical indications: 1) Treatment of deep vein thrombosis with or without pulmonary embolism in patients with mild clinical symptoms, excluding those requiring surgical intervention or thrombolysis; 2) Management of unstable angina and non-Q-wave myocardial infarction to prevent extracorporeal circulation thrombosis during hemodialysis when combined with aspirin; and 3) Treatment of acute ST-segment elevation myocardial infarction in conjunction with thrombolysis or percutaneous coronary intervention (PCI).- Flcube.com