1、 Product introduction
Chinese Name | English Name | Declaration Type | Department | Reportable Dosage Form | Declaration Progress | Strength | CAS |
依折麦布 | Ezetimibe | 5+4 | Hypolipidemia | Tablet, Capsule | Ready to declare | Tablet:10mg Capsule:20mg、40mg | 163222-33-1 |
【Indication】
Primary hypercholesterolemia. It can be used alone or in combination with HMG CoA reducing mould inhibitors (statins) to treat primary (heterozygous familial or non familial) hypercholesterolemia. It can reduce TC, LDL-C and apob. Homozygous familial hypercholesterolemia (hofh) can be used in combination with statins as an adjuvant therapy for other lipid-lowering therapies (such as LDL-C plasma separation and exchange method), or to reduce TC and LDL-C levels in patients with hofh when other lipid-lowering therapies are ineffective. Homozygous sitosteronemia (or phytosterol blood syndrome) this product is used as an adjunctive treatment in addition to diet control to reduce.
【Reportable Dosage Form &Strength】
Tablet:10mg
Capsule:20mg、40mg
【Mechanism of Action】
Cholesterol absorption inhibitors.
【Development Progress】
Ready to declare
二、Domestic Declaration
Declaration Type | Reportable Dosage Form | Number of Declared Preparations | Number of Existing Preparation Enterprises |
5+4 | Tablet, Capsule | Tablet: 1 imported, 15 domestic; Compound tablet: 1 imported, 10 domestic | Tablet: 1 imported; Compound tablet: 2 imported |
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Guangzhou Tosun Pharmaceutical Ltd
FL 4-5,No.3, 2nd Kehui street, Science Park, Guangzhou High-tech Industrial Development Zone, Guangzhou, China. 510663
Tel: +86-20-66392521; Fax: +86-20-66392525