ZYBAN TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPROPION HYDROCHLORIDE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

N06AX12

INN (International Name):

BUPROPION

Dosage:

150MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

BUPROPION HYDROCHLORIDE 150MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIDEPRESSANTS

Product summary:

Active ingredient group (AIG) number: 0131140003; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-07-04

Summary of Product characteristics

_Pr_
_ZYBAN _
_®_
_, Bupropion Hydrochloride _
_ _
_Page 1 of 53 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZYBAN
®
Bupropion Hydrochloride
Extended-Release Tablets, 150 mg, for oral use
Mfr. Std.
Smoking Cessation Aid
Bausch Health, Canada Inc.
Date of initial Authorization:
2150 St-Elzear Blvd. West
July 30, 1998
Laval, Quebec
H7L 4A8
Date of Revision:
December 5, 2023
Control #: 276730
ZYBAN
®
is a registered trademark of the GlaxoSmithKline Groups and is used
under license by Bausch
Health, Canada Inc.
_ _
_ _
_Pr_
_ZYBAN_
_®_
_, Bupropion Hydrochloride _
_ Page 2 of 53 _
_ _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2021
4.1 Dosing Considerations
12/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
12/2023
7 WARNING AND PRECAUTIONS, Immune
12/2021
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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1.2
Geriatrics
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2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
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