ACT PRAVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PRAVASTATIN SODIUM

Beszerezhető a:

ACTAVIS PHARMA COMPANY

ATC-kód:

C10AA03

INN (nemzetközi neve):

PRAVASTATIN

Adagolás:

20MG

Gyógyszerészeti forma:

TABLET

Összetétel:

PRAVASTATIN SODIUM 20MG

Az alkalmazás módja:

ORAL

db csomag:

30/100/500

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2018-06-26

Termékjellemzők

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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
.................................................