BROMAZEPAM-6 - TAB 6MG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-11-2014
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Active ingredient:
BROMAZEPAM
Available from:
PRO DOC LIMITEE
ATC code:
N05BA08
INN (International Name):
BROMAZEPAM
Dosage:
6MG
Pharmaceutical form:
TABLET
Composition:
BROMAZEPAM 6MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0114488001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-06-27
Summary of Product characteristics
1 PRODUCT MONOGRAPH
BROMAZEPAM – 3
BROMAZEPAM – 6
BROMAZEPAM
3 MG AND 6 MG TABLETS
ANXIOLYTIC - SEDATIVE
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
November 7, 2014
Laval, Quebec
H7L 3W9
_Control No.: 179224_
2
TABLE OF CONTENTS
PART I: HEALTH PROFFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
9
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
12
OVERDOSAGE
......................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
15
STORAGE AND STABILITY
...............................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 16
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
...............................................................................
17
CLINICAL TRIALS
...............................................................................................................
18
DETAILED PHARMACOLOGY
....................................................
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