NTP-PRAVASTATIN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

PRAVASTATIN SODIUM

มีจำหน่ายจาก:

TEVA CANADA LIMITED

รหัส ATC:

C10AA03

INN (ชื่อสากล):

PRAVASTATIN

ปริมาณ:

10MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

PRAVASTATIN SODIUM 10MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

HMG-COA REDUCTASE INHIBITORS

สรุปสินค้า:

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

สถานะการอนุญาต:

CANCELLED PRE MARKET

วันที่อนุญาต:

2017-06-13

สรุปลักษณะสินค้า

PRODUCT MONOGRAPH
Pr
NTP-PRAVASTATIN
pravastatin sodium tablets
10, 20 and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166140
Date of Preparation:
July 23, 2013
_ _
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
.............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
16
OVERDOSAGE
...........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 17
STORAGE AND STABILITY
.....................................................................................
19
PART II: SCIENTIFIC INFORMATION
................................................................... 21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
.....................................................................................................
22
DETAILED PHARMACOLOGY
................................................................................
28
TOXICOLOGY
............................................................................................................
29
REFERENCES
................................................