Q-PRAVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAVASTATIN SODIUM

Boleh didapati daripada:

QD PHARMACEUTICALS ULC

Kod ATC:

C10AA03

INN (Nama Antarabangsa):

PRAVASTATIN

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

PRAVASTATIN SODIUM 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2015-08-21

Ciri produk

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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
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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