MYLAN-ATORVASTATIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

C10AA05

INN (nume internaţional):

ATORVASTATIN

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Calea de administrare:

ORAL

Unități în pachet:

90/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HMG-COA REDUCTASE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-10-30

Caracteristicilor produsului

_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