MYLAN-ATORVASTATIN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ATORVASTATIN (ATORVASTATIN CALCIUM)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

C10AA05

INN:

ATORVASTATIN

dosage:

40MG

pharmaceutical_form:

TABLET

composition:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

administration_route:

ORAL

units_in_package:

90/500

prescription_type:

Prescription

therapeutic_area:

HMG-COA REDUCTASE INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2012-10-30

SPC

_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