MINT-ATORVASTATIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Dostępny od:

MINT PHARMACEUTICALS INC

Kod ATC:

C10AA05

INN (International Nazwa):

ATORVASTATIN

Dawkowanie:

80MG

Forma farmaceutyczna:

TABLET

Skład:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HMG-COA REDUCTASE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0133055004; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-08-01

Charakterystyka produktu

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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
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_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
..............................................................................