PRO-LORAZEPAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LORAZEPAM

Available from:

PRO DOC LIMITEE

ATC code:

N05BA06

INN (International Name):

LORAZEPAM

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

LORAZEPAM 2MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0110731002; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-03-22

Summary of Product characteristics

_PRO-LORAZEPAM (Lorazepam Tablets) _
_ _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRO-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg and 2 mg, Oral
USP
Anxiolytic - Sedative
PRO DOC LTÉE
2925, boul. Industriel
Laval Québec
H7L 3W9
Date of Initial Authorization:
OCT 15, 1985
Date of Revision:
AUG 10, 2023
Submission Control Number: 277413
_PRO-LORAZEPAM (Lorazepam Tablets) _
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
03/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
08/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
08/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
03/2022
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
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
.............................