NTP-TELMISARTAN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TELMISARTAN

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

C09CA07

INN (Tên quốc tế):

TELMISARTAN

Liều dùng:

40MG

Dạng dược phẩm:

TABLET

Thành phần:

TELMISARTAN 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0138223001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-06-13

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
NTP-TELMISARTAN
TELMISARTAN TABLETS
TABLETS
40 MG AND 80 MG
Professed standard
Angiotensin II AT1 Receptor Blocker
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
September 30, 2013
Submission Control No: 167609
_NTP-TELMISARTAN Tablets _
_ _
_ _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
.........................................................................................................
22
DETAILED PHARMACOLOGY
............................................