SANDOZ PRAVASTATIN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

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Download Productkenmerken (SPC)
23-06-2017

Werkstoffen:

PRAVASTATIN SODIUM

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

C10AA03

INN (Algemene Internationale Benaming):

PRAVASTATIN

Dosering:

40MG

farmaceutische vorm:

TABLET

Samenstelling:

PRAVASTATIN SODIUM 40MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

HMG-COA REDUCTASE INHIBITORS

Product samenvatting:

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

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2019-08-01

Productkenmerken

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
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: June 2, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 205299
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
........................................................................
                                
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