PRIVA-PRAVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
09-09-2015

Aktiv bestanddel:

PRAVASTATIN SODIUM

Tilgængelig fra:

PHARMAPAR INC

ATC-kode:

C10AA03

INN (International Name):

PRAVASTATIN

Dosering:

20MG

Lægemiddelform:

TABLET

Sammensætning:

PRAVASTATIN SODIUM 20MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100/500

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2022-07-29

Produktets egenskaber

                                _Priva-PRAVASTATIN _
_ _
_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
PRIVA-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
PHARMAPAR INC.
DATE OF PREPARATION:
100-5950, Ch. de la Côte de Liesse
September 1, 2015
Mont-Royal
Qc, H4T 1E2
Control # 186294
_Priva-PRAVASTATIN _
_ _
_Page 2 of 37 _
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
..............................................................................................................
13
DOSAGE AND ADMINISTRATION
..........................................................................................
15
OVERDOSAGE
............................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
16
STORAGE AND STABILITY
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 18
PART II: SCIENTIFIC INFORMATION
.....................................................................................
19
PHARMACEUTICAL INFORMATION
......................................................................................
19
C
                                
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