PRAVASTATIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PRAVASTATIN SODIUM

Verfügbar ab:

SANIS HEALTH INC

ATC-Code:

C10AA03

INN (Internationale Bezeichnung):

PRAVASTATIN

Dosierung:

40MG

Darreichungsform:

TABLET

Zusammensetzung:

PRAVASTATIN SODIUM 40MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100

Verschreibungstyp:

Prescription

Therapiebereich:

HMG-COA REDUCTASE INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-11-03

Fachinformation

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRAVASTATIN
Pravastatin Sodium Tablets
10 mg, 20 mg and 40 mg
Manufacturer’s Standard
Lipid Metabolism Regulator
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
November 9, 2020
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NO.: 244865
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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
...........................................................................................................
18
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
.............