ATORVASTATIN-40 TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Fáanlegur frá:

SIVEM PHARMACEUTICALS ULC

ATC númer:

C10AA05

INN (Alþjóðlegt nafn):

ATORVASTATIN

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

90/100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HMG-COA REDUCTASE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2013-08-29

Vara einkenni

_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN-10
PR
ATORVASTATIN-20
PR
ATORVASTATIN-40
PR
ATORVASTATIN-80
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
Sivem Pharmaceuticals ULC
Date of Initial Authorization:
4705 Dobrin Street
August 29, 2013
Saint-Laurent, Quebec, Canada
H4R 2P7
Date of Revision:
www.sivem.ca
March 14, 2023
Submission Control Number: 268525
_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
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_ _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2023
7 Warnings and Precautions, Musculoskeletal
03/2023
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
...................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................