PRAVACHOL TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

PRAVASTATIN SODIUM

มีจำหน่ายจาก:

BRISTOL-MYERS SQUIBB CANADA

รหัส ATC:

C10AA03

INN (ชื่อสากล):

PRAVASTATIN

ปริมาณ:

20MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

PRAVASTATIN SODIUM 20MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

90

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

HMG-COA REDUCTASE INHIBITORS

สรุปสินค้า:

Active ingredient group (AIG) number: 0122563002; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2020-11-27

สรุปลักษณะสินค้า

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRAVACHOL
®
pravastatin sodium
20 and 40 mg
Lipid Metabolism Regulator
Bristol-Myers Squibb Canada
Montréal, Canada
®
Registered trademark
of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Date of Preparation:
August 16, 1990
Date of Revision:
March 4, 2020
Submission Control No: 234107
_ _
_ _
_Page 2 of 39_
TABLE OF CONTENTS
PRODUCT MONOGRAPH
.........................................................................................................1
TABLE OF CONTENTS
.................................................................................................................2
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
.....................................................................................................
16
DOSAGE AND ADMINISTRATION
.................................................................................
18
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 19
STORAGE AND STABILITY
.............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 21
PART II