ATORVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Available from:

SANIS HEALTH INC

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 40MG

Administration route:

ORAL

Units in package:

500

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0133055003; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-12-18

Summary of Product characteristics

_ATORVASTATIN (atorvastatin calcium) _
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_ Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin
(as atorvastatin calcium propylene glycol solvate), Oral
USP
Lipid Metabolism Regulator
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
July 30, 2020
Date of Revision:
August 22, 2022
Submission Control Number: 265202
_ATORVASTATIN (atorvastatin calcium) _
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_ Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
08/2022
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
...................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4
Administration
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