APO-OXAZEPAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OXAZEPAM

Available from:

APOTEX INC

ATC code:

N05BA04

INN (International Name):

OXAZEPAM

Dosage:

15MG

Pharmaceutical form:

TABLET

Composition:

OXAZEPAM 15MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0102420002; AHFS:

Authorization status:

MARKETED

Authorization date:

1979-12-31

Summary of Product characteristics

_APO-OXAZEPAM (oxazepam tablets) _
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_Page 1 of 28 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
APO-OXAZEPAM
Oxazepam Tablets
Tablets, 10 mg, 15 mg and 30 mg, oral
Apotex Standard
Anxiolytic-Sedative
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUN 21, 1979
Date of Revision:
SEP 05, 2023
Submission Control Number: 273440
_APO-OXAZEPAM (oxazepam tablets) _
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_Page 2 of 28 _
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RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
09/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-Feeding
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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