JAMP-ALPRAZOLAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-07-2018
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Active ingredient:
ALPRAZOLAM
Available from:
JAMP PHARMA CORPORATION
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
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0115008001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-04-01
Summary of Product characteristics
Page 1 of 37
PRODUCT MONOGRAPH
JAMP-ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
JAMP Pharma Corporation
Date of Revision: July 24, 2018
1310 rue Nobel
Boucherville, Québec
J4B 5H3
CONTROL# 217423
Page 2 of 37
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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