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四环医药(00460):利伐沙班片(规格:2.5mg)获国家药监局批准上市

Sihuan Pharm (00460): Rivaroxaban tablet (specification: 2.5mg) has been approved for market by the National Medical Products Administration.

Zhitong Finance ·  Jun 11 12:16

Sihuan Pharm (00460) announced that its subsidiary, Jilin Sihuan Pharmaceutical Co., Ltd. (Jilin Sihuan), has developed...

Sihuan Pharm (00460) announced that a new specification (2.5mg) of the developed drug, Rivaroxaban tablets, by its affiliate Jilin Sihuan Pharmaceutical Co., Ltd. was approved by the China National Medical Products Administration for supplementary application.

A combination of 2.5mg Rivaroxaban tablets and aspirin is equivalent to a new product, and its indication is different from that of the 10mg and 15mg Rivaroxaban tablets already on the market (used for adults with venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), and non-valvular atrial fibrillation). The indication for 2.5mg Rivaroxaban tablets is: Rivaroxaban tablets combined with aspirin (ASA) are used to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adults with coronary artery disease (CAD) or peripheral arterial disease (PAD) who are at high risk of ischemic events. It is considered to have the same quality and efficacy as generic drugs. Sihuan Pharm is the third domestic company to be approved for sale of Rivaroxaban tablets with a specification of 2.5mg.

In addition, Rivaroxaban is a class B national medical insurance variety and a new type of oral anticoagulant widely used in clinical practice. It has the advantages of rapid onset, low incidence of intracranial hemorrhage, and no need for routine coagulation monitoring or routine dose adjustment. The combination of Rivaroxaban and aspirin can significantly improve the prognosis of CAD/PAD patients and is recommended by authoritative guidelines both at home and abroad in Europe, the United States, and China.

The translation is provided by third-party software.


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