ACT PRAVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PRAVASTATIN SODIUM

זמין מ:

ACTAVIS PHARMA COMPANY

קוד ATC:

C10AA03

INN (שם בינלאומי):

PRAVASTATIN

כמות:

20MG

טופס פרצבטיות:

TABLET

הרכב:

PRAVASTATIN SODIUM 20MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/100/500

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:

2018-06-26

מאפייני מוצר

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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
ACT PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
June 2, 2017
Submission Control No: 205793
_ _
_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
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
.................................................