SANDOZ ATORVASTATIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ATORVASTATIN (ATORVASTATIN CALCIUM)

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

C10AA05

INN (الاسم الدولي):

ATORVASTATIN

جرعة:

20MG

الشكل الصيدلاني:

TABLET

تركيب:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

HMG-COA REDUCTASE INHIBITORS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2010-05-19

خصائص المنتج

_Sandoz Atorvastatin _
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_Page 1 of 63_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Initial Authorization:
May 19, 2010
Date of Revision:
September 11, 2023
Submission Control Number: 274576
_Sandoz Atorvastatin _
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_Page 2 of 63_
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RECENT MAJOR LABEL CHANGES
2 Contraindications
7 Warnings and Precautions, Musculoskeletal
09/2023
7 Warnings and Precautions, Musculoskeletal
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
......................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4