RIVA-ALPRAZOLAM TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ALPRAZOLAM

Saatavilla:

LABORATOIRE RIVA INC.

ATC-koodi:

N05BA12

INN (Kansainvälinen yleisnimi):

ALPRAZOLAM

Annos:

2MG

Lääkemuoto:

TABLET

Koostumus:

ALPRAZOLAM 2MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Targeted (CDSA IV)

Terapeuttinen alue:

BENZODIAZEPINES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0115008004; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2017-07-04

Valmisteyhteenveto

PRODUCT MONOGRAPH
RIVA-ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
LABORATOIRE RIVA INC
. Date of Revision:
660 Boul. Industriel June 29, 2018
Blainville, Québec
J7C 3V4
www.labriva.com
CONTROL# 216392
_Product Monograph – Riva-Alprazolam _
_ _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................................
5
ADVERSE REACTIONS
............................................................................................................
12
DRUG INTERACTIONS
............................................................................................................
16
DOSAGE AND ADMINISTRATION
........................................................................................
19
OVERDOSAGE
...........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
......................................................................
24
PHARMACEUTICAL INFORMATION
....................................................................................
24
CLINICAL TRIALS
.........................................................