TEVA-PRAVASTATIN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
14-07-2020
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ingredients actius:
PRAVASTATIN SODIUM
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
C10AA03
Designació comuna internacional (DCI):
PRAVASTATIN
Dosis:
40MG
formulario farmacéutico:
TABLET
Composición:
PRAVASTATIN SODIUM 40MG
Vía de administración:
ORAL
Unidades en paquete:
30/100
tipo de receta:
Prescription
Área terapéutica:
HMG-COA REDUCTASE INHIBITORS
Resumen del producto:
Active ingredient group (AIG) number: 0122563003; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2003-01-08
Fitxa tècnica
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PRAVASTATIN
pravastatin sodium
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2020
Toronto, Ontario
Canada M1B 2K9
SUBMISSION CONTROL NO:
240026
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2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................
5
ADVERSE REACTIONS
.............................................................................................
11
DRUG INTERACTIONS
.............................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................
17
OVERDOSAGE
...........................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.................................................
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