JAMP-PRAVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAVASTATIN SODIUM

Boleh didapati daripada:

JAMP PHARMA CORPORATION

Kod ATC:

C10AA03

INN (Nama Antarabangsa):

PRAVASTATIN

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

PRAVASTATIN SODIUM 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2015-06-19

Ciri produk

Page 1 of 39
PRODUCT MONOGRAPH
Pr
JAMP-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
July 8, 2020
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No.: 240031
Page 2 of 39
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
........................................................................................................................
11
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 INFORMAT