ATORVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ATORVASTATIN (ATORVASTATIN CALCIUM)

זמין מ:

SIVEM PHARMACEUTICALS ULC

קוד ATC:

C10AA05

INN (שם בינלאומי):

ATORVASTATIN

כמות:

40MG

טופס פרצבטיות:

TABLET

הרכב:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

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: 0133055003; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-05-09

מאפייני מוצר

_ATORVASTATIN Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
Sivem Pharmaceuticals ULC
4705 Dobrin Street
DATE OF REVISION:
September 26, 2017
Saint-Laurent, Quebec
H4R 2P7
Submission Control No.: 209551
_ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
_ _
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
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATIO