NTP-TELMISARTAN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

TELMISARTAN

Saadav alates:

TEVA CANADA LIMITED

ATC kood:

C09CA07

INN (Rahvusvaheline Nimetus):

TELMISARTAN

Annus:

40MG

Ravimvorm:

TABLET

Koostis:

TELMISARTAN 40MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2017-06-13

Toote omadused

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