RATIO-PRAVASTATIN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PRAVASTATIN SODIUM

Dostupné s:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC kód:

C10AA03

INN (Mezinárodní Name):

PRAVASTATIN

Dávkování:

40MG

Léková forma:

TABLET

Složení:

PRAVASTATIN SODIUM 40MG

Podání:

ORAL

Jednotky v balení:

30/100

Druh předpisu:

Prescription

Terapeutické oblasti:

HMG-COA REDUCTASE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0122563003; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2014-09-19

Charakteristika produktu

Product Monograph – ratio-PRAVASTATIN
Page 1 of 40
PRODUCT MONOGRAPH
PR
RATIO-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
_ _
_ _
_ _
_ _
RATIOPHARM INC.
17 800 Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Date of Revision:
April 12, 2011
Submission Control No: 145497
Product Monograph – ratio-PRAVASTATIN
Page 2 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.......................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................................
3
CONTRAINDICATIONS
....................................................................................................................
5
ADVERSE
REACTIONS..................................................................................................................11
DRUG
INTERACTIONS...................................................................................................................15
OVERDOSAGE
.................................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY..........................................................................18
STORAGE AND
STABILITY..........................................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................20
PART II: SCIENTIFIC INFORMATION
................................................................................21
CLINICAL
TRIALS...........................................................................................................................22
DETAILED
PHARMACOLOGY....................................................................................................27
REFERENCES....................................................