ZYBAN TABLET (EXTENDED-RELEASE)

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

BUPROPION HYDROCHLORIDE

Tillgänglig från:

BAUSCH HEALTH, CANADA INC.

ATC-kod:

N06AX12

INN (International namn):

BUPROPION

Dos:

150MG

Läkemedelsform:

TABLET (EXTENDED-RELEASE)

Sammansättning:

BUPROPION HYDROCHLORIDE 150MG

Administreringssätt:

ORAL

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS ANTIDEPRESSANTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2001-07-04

Produktens egenskaper

_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
.........................................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..........................................................................................................................
4
1.1
Pediatrics
..............................................................................................................................4
1.2
Geriatrics
..............................................................................................................................4
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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