SANDOZ PRAVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PRAVASTATIN SODIUM

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

C10AA03

INN (שם בינלאומי):

PRAVASTATIN

כמות:

20MG

טופס פרצבטיות:

TABLET

הרכב:

PRAVASTATIN SODIUM 20MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/100/250/500

סוג מרשם:

Prescription

איזור תרפויטי:

HMG-COA REDUCTASE INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2017-05-29

מאפייני מוצר

PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
Page 2 of 41
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
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
............................................................................................................