VYTORIN

This brand name is authorized in United States. It is also authorized in Australia, Brazil, Ecuador, Germany, Hong Kong SAR China, Italy, Mexico, Singapore, Spain.

Active ingredients

The drug VYTORIN contains a combination of these active pharmaceutical ingredients (APIs):

1
UNII EOR26LQQ24 - EZETIMIBE
 

Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol. The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol.

 
Read more about Ezetimibe
2
UNII AGG2FN16EV - SIMVASTATIN
 

Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.

 
Read more about Simvastatin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 VYTORIN Tablet MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
C10BA02 Simvastatin and ezetimibe C Cardiovascular system → C10 Lipid modifying agents → C10B Lipid modifying agents, combinations → C10BA Combinations of various lipid modifying agents
Discover more medicines within C10BA02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 8881K, 8882L, 9483D, 9484E
BR Câmara de Regulação do Mercado de Medicamentos 525503402114214, 525503403110212, 525503404117210, 525503405113219, 525503406111211, 525503407116215, 525516020019403, 525516020019503, 525516020019603
DE Bundesinstitut für Arzneimittel und Medizinprodukte 15293338, 17309718
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 25.819-08-04, 25.820-08-04, 25.822-08-04
ES Centro de información online de medicamentos de la AEMPS 66571, PA1286-062-002, PA1286-062-003
HK Department of Health Drug Office 53014, 53016, 53017
IT Agenzia del Farmaco 036690067, 036690218, 036690360
MX Comisión Federal para la Protección contra Riesgos Sanitarios 127M2004
SG Health Sciences Authority 13011P, 13012P
US FDA, National Drug Code 55289-280, 55289-520, 66582-311, 66582-312, 66582-313, 66582-315

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