ATORVASTATIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ATORVASTATIN (ATORVASTATIN CALCIUM)

متاح من:

SIVEM PHARMACEUTICALS ULC

ATC رمز:

C10AA05

INN (الاسم الدولي):

ATORVASTATIN

جرعة:

20MG

الشكل الصيدلاني:

TABLET

تركيب:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

HMG-COA REDUCTASE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0133055002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2017-11-15

خصائص المنتج

_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