APO-BROMAZEPAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-10-2022
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Active ingredient:
BROMAZEPAM
Available from:
APOTEX INC
ATC code:
N05BA08
INN (International Name):
BROMAZEPAM
Dosage:
3MG
Pharmaceutical form:
TABLET
Composition:
BROMAZEPAM 3MG
Administration route:
ORAL
Units in package:
100,500
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0114488003; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-01-20
Summary of Product characteristics
_Page 1 of 28 _
PRODUCT MONOGRAPH
APO-BROMAZEPAM
Bromazepam Tablets
Tablets, 1.5 mg, 3 mg and 6 mg
Apotex Standard
Anxiolytic - Sedative
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control No.: 267486
Date of
Revision:
OCT
18, 2022
_Page 2 of 28 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRAT ION
...................................................................................
12
OVERDOSAGE
......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 15
STORAGE AND STABILITY
...............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
............................................................................
16
DOSAGE FORMS, COMPOSITION, AND PACKAGING
................................................. 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
...............................................................................
17
CLINICAL TRIALS
..................................
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