Ezetimibe and Simvastatin

Overview

No overview information available.

Indication

⑴原发性高胆固醇血症：适用于原发性（杂合子家族性或非家族性）高胆固醇血症或混合性高脂血症患者饮食控制以外的辅助治疗。本品可降低总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、载脂蛋白B（Apo B）、甘油三酯（TG）和非高密度脂蛋白胆固醇（non-HDL-C）水平，并能升高高密度脂蛋白胆固醇（HDL-C）水平。 ⑵纯合子家族性高胆固醇血症（HoFH）：适用于降低HoFH 患者的TC和LDL-C水平。本品可作为其他降脂治疗（例如LDL血浆分离置换法）的辅助疗法；或其他降脂治疗无效时用于降低HoFH患者的TC和LDL-C水平。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer	2024/05/31	NCT06437574	Phase 2	Recruiting	Cedars-Sinai Medical Center
A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males	2015/09/11	NCT02547402	Phase 1	Completed	Complexa, Inc.
Statins for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy	2014/05/02	NCT02129231	Phase 2	Completed	University of Guadalajara
Vascular and Metabolic Effects of Vytorin vs Simvastatin	2012/08/16	NCT01666067	Phase 4	Completed	Gachon University Gil Medical Center
Vascular and Metabolic Effects of Vytorin	2012/08/09	NCT01660945	Phase 4	Completed	Gachon University Gil Medical Center
A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)	2012/04/30	NCT01587235	Phase 4	Withdrawn	Organon and Co
Vytorin in the Treatment of Alopecia Areata	2012/01/27	NCT01520077	Phase 1	Completed	University of Miami
To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects	2011/08/19	NCT01420328	Not Applicable	Completed	University at Buffalo
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.	2009/10/02	NCT00988364	Phase 4	Completed	Baylor College of Medicine
Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)	2009/06/23	NCT00926055	Not Applicable	Withdrawn	Korea University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Glenmark Pharmaceuticals Reaches $7M Settlement in US Antitrust Lawsuits Over Cholesterol Drugs

5 months ago

• Glenmark Pharmaceuticals has agreed to pay $7 million to settle antitrust lawsuits with three major healthcare entities - Humana, Centene, and Kaiser - over generic cholesterol medications Zetia and Vytorin. • The lawsuits alleged that Glenmark entered an anticompetitive agreement in 2010 with Schering Corporation and MSP Singapore Company LLC regarding patent infringement litigation for ezetimibe. • While reaching the settlement agreement, Glenmark explicitly denies all allegations and maintains the settlement does not indicate any admission of liability or illegal conduct.

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