XANAX TS TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-04-2023
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Active ingredient:
ALPRAZOLAM
Available from:
BGP PHARMA ULC
ATC code:
N05BA12
INN (International Name):
ALPRAZOLAM
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
ALPRAZOLAM 2MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0115008004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-05-01
Summary of Product characteristics
PRODUCT MONOGRAPH
XANAX
®
alprazolam tablets USP
0.25 mg, 0.5 mg and 1 mg tablets
XANAX TS
®
alprazolam tablets USP
2 mg triscored tablets
ANXIOLYTIC - ANTIPANIC
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
Canada, M8Z 2S6
Submission Control No: 273630
®
UPJOHN US 2 LLC
BGP Pharma ULC, a Viatris company, Licensee
©
BGP Pharma ULC, 2023
Date
of
Preparation:
APR
20, 2023
_ _
_XANAX and XANAX TS (alprazolam) _
_–_
_ Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
.........................
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