TEVA-PRAVASTATIN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

PRAVASTATIN SODIUM

Saadav alates:

TEVA CANADA LIMITED

ATC kood:

C10AA03

INN (Rahvusvaheline Nimetus):

PRAVASTATIN

Annus:

20MG

Ravimvorm:

TABLET

Koostis:

PRAVASTATIN SODIUM 20MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100

Retsepti tüüp:

Prescription

Terapeutiline ala:

HMG-COA REDUCTASE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2003-01-08

Toote omadused

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PRAVASTATIN
pravastatin sodium
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2020
Toronto, Ontario
Canada M1B 2K9
SUBMISSION CONTROL NO:
240026
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2
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
...........................................................................................................
19
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
................................................................................
30
TOXICOLOGY
.................................................