XANAX TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ALPRAZOLAM

Disponible depuis:

BGP PHARMA ULC

Code ATC:

N05BA12

DCI (Dénomination commune internationale):

ALPRAZOLAM

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

ALPRAZOLAM 1MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Targeted (CDSA IV)

Domaine thérapeutique:

BENZODIAZEPINES

Descriptif du produit:

Active ingredient group (AIG) number: 0115008003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-05-01

Résumé des caractéristiques du produit

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