PRZ-ATORVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Available from:

PHARMARIS CANADA INC

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-10-22

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRZ-ATORVASTATIN
Atorvastatin calcium tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium), Oral
USP
LIPID METABOLISM REGULATOR
Pharmaris Canada Inc.
8310-130 Street, Suite 102
Surrey, British Columbia
Canada, V3W 8J9
Date of Initial Authorization:
OCT 22, 2021
Date of Revision:
FEB 15, 2023
Submission Control No: 268085
_ PRZ-ATORVASTATIN (atorvastatin calcium) _
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RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
02/2023
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
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2
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................
4
1
INDICATIONS
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4
1.1
Pediatrics............................................................................................................
4
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND
ADMINISTRATION........................................................................................
5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 6
4.4
Administration
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8
4.5
Missed dose
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