AVA-PRAVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PRAVASTATIN SODIUM

זמין מ:

AVANSTRA INC

קוד ATC:

C10AA03

INN (שם בינלאומי):

PRAVASTATIN

כמות:

40MG

טופס פרצבטיות:

TABLET

הרכב:

PRAVASTATIN SODIUM 40MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

HMG-COA REDUCTASE INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2011-12-12

מאפייני מוצר

Page 1 of 42
PRODUCT MONOGRAPH
Pr
AVA-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
AVANSTRA INC. DATE OF PREPARATION:
10761 – 25TH NE, SUITE 110, BUILDING “B” FEBRUARY 21, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL NO.: 145177
Page 2 of 42
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.......................................................................................................
10
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
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.......