NTP-ATENOLOL/CHLORTHALIDONE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
19-07-2013
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Werkstoffen:
ATENOLOL; CHLORTHALIDONE
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
C07CB03
INN (Algemene Internationale Benaming):
ATENOLOL AND OTHER DIURETICS
Dosering:
50MG; 25MG
farmaceutische vorm:
TABLET
Samenstelling:
ATENOLOL 50MG; CHLORTHALIDONE 25MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
BETA-ADRENERGIC BLOCKING AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0216877002; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2015-08-06
Productkenmerken
PRODUCT MONOGRAPH
Pr
NTP-ATENOLOL/CHLORTHALIDONE
(atenolol/chlorthalidone tablets, USP)
50/25 mg and 100/25 mg
Antihypertensive Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
July 12, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165857
_Page _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
13
DOSAGE AND ADMINISTRATION
..............................................................................
15
OVERDOSAGE
.................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 17
STORAGE AND STABILITY
..........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
..........................................................................
20
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
..................................................................................
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