SIMVASTATIN TABLETS

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

SIMVASTATIN

Disponible des:

RANBAXY PHARMACEUTICALS CANADA INC.

Codi ATC:

C10AA01

Designació comuna internacional (DCI):

SIMVASTATIN

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

SIMVASTATIN 10MG

Vía de administración:

ORAL

Unidades en paquete:

21/30/1000

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0122415004; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2009-08-13

Fitxa tècnica

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_Page 1 of 45_
PRODUCT MONOGRAPH
SIMVASTATIN TABLETS
(SIMVASTATIN)
USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 21,
2009
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
SUBMISSION CONTROL NO: 131952
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_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONS AND CLINICAL
USE.............................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND
PRECAUTIONS.................................................................................5
ADVERSE
REACTIONS..................................................................................................12
DRUG
INTERACTIONS..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
...............................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
...........................................................19
STORAGE AND
STABILITY.........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................19
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.........................................................................21
CLINICAL
TRIALS.........................................................................................................22
DETAILED
PHARMACOLOGY................................................