SANDOZ PRAVASTATIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PRAVASTATIN SODIUM

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

C10AA03

INN (International ime):

PRAVASTATIN

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

PRAVASTATIN SODIUM 20MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100/250/500

Tip recepta:

Prescription

Područje terapije:

HMG-COA REDUCTASE INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2017-05-29

Svojstava lijeka

PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
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
.........................................................................................................
11
DRUG INTERACTIONS
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
18
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
............................................................................................................