NTP-TELMISARTAN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
29-10-2013
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Werkstoffen:
TELMISARTAN
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
C09CA07
INN (Algemene Internationale Benaming):
TELMISARTAN
Dosering:
40MG
farmaceutische vorm:
TABLET
Samenstelling:
TELMISARTAN 40MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/500
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0138223001; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2017-06-13
Productkenmerken
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
............................................
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