MINT-ATORVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Beszerezhető a:

MINT PHARMACEUTICALS INC

ATC-kód:

C10AA05

INN (nemzetközi neve):

ATORVASTATIN

Adagolás:

10MG

Gyógyszerészeti forma:

TABLET

Összetétel:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Az alkalmazás módja:

ORAL

db csomag:

100/500

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0133055001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2018-08-01

Termékjellemzők

_ _
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_MINT-ATORVASTATIN (atorvastatin calcium) _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg Atorvastatin (as Atorvastatin
Calcium Trihydrate), Oral
USP
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Canada
Date of Initial Authorization:
November 03, 2022
Date of Revision:
August 31, 2023
Submission Control Number: 274869
_ _
_ _
_ _
_MINT-ATORVASTATIN (atorvastatin calcium) _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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
..............................................................................