RIVA-ALPRAZOLAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-06-2018
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Active ingredient:
ALPRAZOLAM
Available from:
LABORATOIRE RIVA INC.
ATC code:
N05BA12
INN (International Name):
ALPRAZOLAM
Dosage:
0.25MG
Pharmaceutical form:
TABLET
Composition:
ALPRAZOLAM 0.25MG
Administration route:
ORAL
Units in package:
100/500/1000
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0115008001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-10-30
Summary of Product characteristics
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
.........................................................
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