原创公式规律四肖中特
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HNSP received Drug Registration Approval for Bivalirudin

2019-01-30 14:06      

一、Hainan Shuangcheng Pharmaceuticals Co.,Ltd. has received the Drug Registration Approval Letter for Bivalirudin forInjection from National Medical Products Administration and the Letter numberis 2019S00024:

1Drug approvalnumber: National Drug Approval Number (GUOYAOZHUNZI) H20193019

2Product name:Zhusheyong Bifaluding

3English name: Bivalirudinfor Injection

4Dosage form:Injection

5Strength: 250 mg

6Manufacturer:Hainan Shuangcheng Pharmaceuticals Co., Ltd.

7、Manufacturingsite: No. 16 Xingguo Road, Xiuying District, Haikou City, Hainan Province

8Application item: Nationaldrug registration

9Registrationcategory: Category 6 of Chemical Drugs

10Approval date: January15 2019

11Expiration date of drug approval numb er: January 14 2024

 

In June 2018, Hainan Shuangchengreceived Tentative Approval from USFDA for Bivalirudin for Injection, and theANDA number is 210031.

Bivalirudinis a direct thrombin inhibitor used to prevent coagulation of blood. And theUSFDA approved indications of Bivalirudin for Injection are: indicated for useas an anticoagulant in patients undergoing percutaneous transluminal coronaryangioplasty (PTCA); indicated for use as an anticoagulant in patientsundergoing percutaneous coronary intervention (PCI); indicated for patientswith, or at risk of Heparin Induced Thrombocytopenia (HIT) or Heparin InducedThrombosis-Thrombocytopenia Syndrome (HITTS) undergoing PCI.

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