RIVA-PRAVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PRAVASTATIN SODIUM

Saatavilla:

LABORATOIRE RIVA INC.

ATC-koodi:

C10AA03

INN (Kansainvälinen yleisnimi):

PRAVASTATIN

Annos:

40MG

Lääkemuoto:

TABLET

Koostumus:

PRAVASTATIN SODIUM 40MG

Antoreitti:

ORAL

Kpl paketissa:

30/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2017-11-27

Valmisteyhteenveto

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
..........