ACT PRAVASTATIN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PRAVASTATIN SODIUM

Dostupné s:

ACTAVIS PHARMA COMPANY

ATC kód:

C10AA03

INN (Mezinárodní Name):

PRAVASTATIN

Dávkování:

20MG

Léková forma:

TABLET

Složení:

PRAVASTATIN SODIUM 20MG

Podání:

ORAL

Jednotky v balení:

30/100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

HMG-COA REDUCTASE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0122563002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-06-26

Charakteristika produktu

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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
ACT PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
June 2, 2017
Submission Control No: 205793
_ _
_Page 2 of 44_
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
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
.................................................