Bivalirudin for Injection has obtained marketing authorization from the Therapeutic Goods Administration (TGA) of Australia.2025.5.9
2025-11-18 10:25
Bivalirudin for Injection has obtained marketing authorization from the Therapeutic Goods Administration (TGA) of Australia.
Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the Australia Therapeutic Goods Administration (TGA) that the Bivalirudin for Injection submitted was granted market authorization.
Product detail
The name of the drug: Bivalirudin for Injection
Dosage form: Sterile injection
Strength: 250mg
Indication:Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing medium or high risk Acute Coronary Syndrome (ACS)( unstable angina, non-ST-segment elevation myocardial infarction), and patients receiving early invasive treatment , also that receiving percutaneous coronary intervention (PCI) . Intended to be used in combination with aspirin or P2Y12 antagonist (e.g., Clopidogrel or Ticlopidine )
The Australia TGA’s final approval of the Bivalirudin for Injection indicates the product developed by the company has reached the international level in terms of safety and effectiveness. The company advances the entering of the product in the Australia market.
Product detail
The name of the drug: Bivalirudin for Injection
Dosage form: Sterile injection
Strength: 250mg
Indication:Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing medium or high risk Acute Coronary Syndrome (ACS)( unstable angina, non-ST-segment elevation myocardial infarction), and patients receiving early invasive treatment , also that receiving percutaneous coronary intervention (PCI) . Intended to be used in combination with aspirin or P2Y12 antagonist (e.g., Clopidogrel or Ticlopidine )
The Australia TGA’s final approval of the Bivalirudin for Injection indicates the product developed by the company has reached the international level in terms of safety and effectiveness. The company advances the entering of the product in the Australia market.
