SANDOZ ATORVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

C10AA05

INN (International Name):

ATORVASTATIN

Dosering:

40MG

Lægemiddelform:

TABLET

Sammensætning:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/500

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2010-05-19

Produktets egenskaber

_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