GD-ATORVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Saatavilla:

GENMED A DIVISION OF PFIZER CANADA ULC

ATC-koodi:

C10AA05

INN (Kansainvälinen yleisnimi):

ATORVASTATIN

Annos:

40MG

Lääkemuoto:

TABLET

Koostumus:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Antoreitti:

ORAL

Kpl paketissa:

90/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2017-03-10

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
GD
®
-ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
GenMed, a division of Pfizer Canada Inc.
17 300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision:
May 16, 2017
GD
®
is a trademark of Pfizer Canada Inc.
GenMed a division of Pfizer Canada Inc., Licensee
Submission Control No.: 204824
_GD_
®
_-ATORVASTATIN_
_(atorvastatin calcium) Product Monograph _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................14
OVERDOSAGE.................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL
INFORMATION..........................................................................29
CLINICAL TRIALS
...................