AURO-PRAVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PRAVASTATIN SODIUM

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

C10AA03

INN (International Name):

PRAVASTATIN

Dosering:

10MG

Lægemiddelform:

TABLET

Sammensætning:

PRAVASTATIN SODIUM 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/500

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0122563001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2016-11-21

Produktets egenskaber

Page 1 of 40
PRODUCT MONOGRAPH
PR
AURO-PRAVASTATIN
Pravastatin Tablets, BP
10 mg, 20 mg and 40 mg of pravastatin sodium
Lipid Metabolism Regulator
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
August 7, 2020
SUBMISSION CONTROL NO:
239425
Page 2 of 40
TABLE OF CONTENTS
PART I:
HEALTH PROFESSIONAL INFORMATION.......………..............
3
SUMMARY PRODUCT INFORMATION ....................….............
3
INDICATIONS AND CLINICAL USE .....................……..............
3
CONTRAINDICATIONS
.........................................………........... 5
WARNINGS AND PRECAUTIONS
..........................…….............. 6
ADVERSE REACTIONS
....................................………….............
11
DRUG INTERACTIONS
.............................……………................ 16
DOSAGE AND ADMINISTRATION .............…............................
18
OVERDOSAGE
......................................………….........................
19
ACTION AND CLINICAL PHARMACOLOGY….........................
19
STORAGE AND STABILITY
........................................…….......... 22
DOSAGE FORMS, COMPOSITION AND PACKAGING…….....
22
PART II:
SCIENTIFIC INFORMATION
.........................…………….….......
23
PHARMACEUTICAL INFORMATION ........................….............
23
CLINICAL TRIALS
...............................................……………......
24
DETAILED PHARMACOLOGY ..............................……………..
30
TOXICOLOGY
...........................…………………………............
31
REFERENCE…...................................………………………….....
36
PART III:
CONSUMER INFORMATION.....................………………….......
41
Page 3 of 40
PR
AURO-PRAVASTATIN
Pravastatin Tablets, BP
10 mg, 20 mg and 40 mg of pravastatin sodium
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS