RIVA-PRAVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PRAVASTATIN SODIUM

Beszerezhető a:

LABORATOIRE RIVA INC.

ATC-kód:

C10AA03

INN (nemzetközi neve):

PRAVASTATIN

Adagolás:

40MG

Gyógyszerészeti forma:

TABLET

Összetétel:

PRAVASTATIN SODIUM 40MG

Az alkalmazás módja:

ORAL

db csomag:

30/100

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2017-11-27

Termékjellemzők

PRODUCT MONOGRAPH
PR
RIVA-PRAVASTATIN
Pravastatin Sodium Tablets, House Standard
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Date of Revision:
June 15, 2017
Submission Control No: 206124
_ _
_RIVA-PRAVASTATIN Product Monograph _
_Page 2 of 41_
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
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
..........................................................................................................
22
DETAILED PHARMACOLOGY
..........