MYLAN-ATORVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

C10AA05

INN (International Name):

ATORVASTATIN

Dosering:

20MG

Lægemiddelform:

TABLET

Sammensætning:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

Indgivelsesvej:

ORAL

Enheder i pakken:

90/500

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0133055002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-10-30

Produktets egenskaber

_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYLAN-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
OCT 30, 2012
Date of Revision:
OCT 23, 2023
Submission Control Number: 275378
_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
10/2023
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
........................................................ 6
4.4
Administration