NTP-TELMISARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TELMISARTAN

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

C09CA07

INN (Medzinárodný Name):

TELMISARTAN

Dávkovanie:

40MG

Forma lieku:

TABLET

Zloženie:

TELMISARTAN 40MG

Spôsob podávania:

ORAL

Počet v balení:

30/500

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2017-06-13

Súhrn charakteristických

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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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
............................................