Q-PRAVASTATIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PRAVASTATIN SODIUM

Dostupno od:

QD PHARMACEUTICALS ULC

ATC koda:

C10AA03

INN (International ime):

PRAVASTATIN

Doziranje:

40MG

Farmaceutski oblik:

TABLET

Sastav:

PRAVASTATIN SODIUM 40MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100

Tip recepta:

Prescription

Područje terapije:

HMG-COA REDUCTASE INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2015-08-21

Svojstava lijeka

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PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
_Page 2 of _
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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 ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32