PRAVASTATIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PRAVASTATIN SODIUM

Disponible depuis:

COBALT PHARMACEUTICALS COMPANY

Code ATC:

C10AA03

DCI (Dénomination commune internationale):

PRAVASTATIN

Dosage:

40MG

forme pharmaceutique:

TABLET

Composition:

PRAVASTATIN SODIUM 40MG

Mode d'administration:

ORAL

Unités en paquet:

30/100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0122563003; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2017-09-01

Résumé des caractéristiques du produit

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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
February 20, 2012
Submission Control No: 153301
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_Page 2 of 44_
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
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS.........................................................................................................
24
DETAILED
PHARMACOLOGY.................................................