TEVA-BROMAZEPAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-07-2021
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
BROMAZEPAM
Available from:
TEVA CANADA LIMITED
ATC code:
N05BA08
INN (International Name):
BROMAZEPAM
Dosage:
6MG
Pharmaceutical form:
TABLET
Composition:
BROMAZEPAM 6MG
Administration route:
ORAL
Units in package:
100/500/1000
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0114488001; AHFS:
Authorization status:
APPROVED
Authorization date:
1997-02-04
Summary of Product characteristics
_ _
PRODUCT MONOGRAPH
TEVA-BROMAZEPAM
Bromazepam Tablets
3 mg and 6 mg
Anxiolytic-Sedative
Teva Canada Limited Date of Revision:
30 Novopharm Court July 27, 2021
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No: 248570
_Page 2 of 28 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................
3
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................
4
ADVERSE REACTIONS
.....................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................
11
DOSAGE AND ADMINISTRATION
................................................................................
12
OVERDOSAGE
..................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 14
STORAGE AND STABILITY
.............................................................................................
15
SPECIAL HANDLING
INSTRUCTIONS............................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
17
PHARMACEUTICAL
INFORMATION.............................................................................
17
CLINICAL TRIALS
.........................................................................................
Read the complete document
