PRO-OXAZEPAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OXAZEPAM

Available from:

PRO DOC LIMITEE

ATC code:

N05BA04

INN (International Name):

OXAZEPAM

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

OXAZEPAM 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0102420003; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-04-13

Summary of Product characteristics

_PRO-OXAZEPAM (oxazepam) _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
T\C PRO-OXAZEPAM
Oxazepam Tablets, Mfr. Std.
Tablets, 10 mg, 15 mg and 30 mg, Oral
Manufacturer’s Standard
Anxiolytic-Sedative
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Initial Authorization:
April 13, 2022
Date of Revision:
February 20, 2023
Submission Control Number: 271773
_PRO-OXAZEPAM (oxazepam) _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
02/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
02/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
02/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
02/2023
7 WARNINGS AND PRECAUTIONS
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-Feeding
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
..............................................................