PMS-ATORVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Beszerezhető a:

PHARMASCIENCE INC

ATC-kód:

C10AA05

INN (nemzetközi neve):

ATORVASTATIN

Adagolás:

10MG

Gyógyszerészeti forma:

TABLET

Összetétel:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Az alkalmazás módja:

ORAL

db csomag:

90/500

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2019-07-31

Termékjellemzők

PRODUCT MONOGRAPH
PR
PMS-ATORVASTATIN
(Atorvastatin Calcium Tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 30, 2016
Submission Control No: 195540
_ _
_pms-ATORVASTATIN Product Monograph _
_Page 2 of 52 _
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
...........................