NTP-TELMISARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-10-2013
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Active ingredient:
TELMISARTAN
Available from:
TEVA CANADA LIMITED
ATC code:
C09CA07
INN (International Name):
TELMISARTAN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
TELMISARTAN 40MG
Administration route:
ORAL
Units in package:
30/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0138223001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-06-13
Summary of Product characteristics
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 _
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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
............................................
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