ZYBAN TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

BUPROPION HYDROCHLORIDE

제공처:

BAUSCH HEALTH, CANADA INC.

ATC 코드:

N06AX12

INN (International Name):

BUPROPION

복용량:

150MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

BUPROPION HYDROCHLORIDE 150MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTIDEPRESSANTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2001-07-04

제품 특성 요약

_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
...........................................................................................................................
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
.......................................................................
5
4
DOSAGE AND ADMINISTRATION
..................