SANDOZ ATORVASTATIN TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

C10AA05

INN (International namn):

ATORVASTATIN

Dos:

40MG

Läkemedelsform:

TABLET

Sammansättning:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Administreringssätt:

ORAL

Enheter i paketet:

30/100/500

Receptbelagda typ:

Prescription

Terapiområde:

HMG-COA REDUCTASE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2010-05-19

Produktens egenskaper

_Sandoz Atorvastatin _
_ _
_Page 1 of 63_
_ _
_ _
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 _
_ _
_Page 2 of 63_
_ _
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