PRAVACHOL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PRAVASTATIN SODIUM

Disponible des:

BRISTOL-MYERS SQUIBB CANADA

Codi ATC:

C10AA03

Designació comuna internacional (DCI):

PRAVASTATIN

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

PRAVASTATIN SODIUM 20MG

Vía de administración:

ORAL

Unidades en paquete:

90

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0122563002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2020-11-27

Fitxa tècnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRAVACHOL
®
pravastatin sodium
20 and 40 mg
Lipid Metabolism Regulator
Bristol-Myers Squibb Canada
Montréal, Canada
®
Registered trademark
of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Date of Preparation:
August 16, 1990
Date of Revision:
March 4, 2020
Submission Control No: 234107
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_Page 2 of 39_
TABLE OF CONTENTS
PRODUCT MONOGRAPH
.........................................................................................................1
TABLE OF CONTENTS
.................................................................................................................2
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
.....................................................................................................
16
DOSAGE AND ADMINISTRATION
.................................................................................
18
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 19
STORAGE AND STABILITY
.............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 21
PART II