NU-PRAVASTATIN TABLETS

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PRAVASTATIN SODIUM

Dostupno od:

NU-PHARM INC

ATC koda:

C10AA03

INN (International ime):

PRAVASTATIN

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

PRAVASTATIN SODIUM 20MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500

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:

2012-09-04

Svojstava lijeka

Page 1 of 42
PRODUCT MONOGRAPH
Pr
NU-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
NU-PHARM INC.
1165 CREDITSTONE ROAD, UNIT 2
VAUGHAN, ON
DATE OF REVISION:
L4K 4N7
MARCH 3, 2011
_CONTROL # 144758 _
Page 2 of 42
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
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE......................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND
STABILITY...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.....................................