WELLBUTRIN XL TABLET (EXTENDED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

BUPROPION HYDROCHLORIDE

Tilgængelig fra:

BAUSCH HEALTH, CANADA INC.

ATC-kode:

N06AX12

INN (International Name):

BUPROPION

Dosering:

300MG

Lægemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensætning:

BUPROPION HYDROCHLORIDE 300MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTIDEPRESSANTS

Produkt oversigt:

Active ingredient group (AIG) number: 0131140004; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-06-11

Produktets egenskaber

_Pr_
_WELLBUTRIN_
_®_
_ XL, Bupropion Hydrochloride _
_ _
_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
WELLBUTRIN
® XL
Bupropion Hydrochloride
Extended-Release Tablets, 150 mg and 300 mg, for oral use
USP
Antidepressant
Bausch Health, Canada Inc.
Date of Initial Authorization:
2150 St-Elzear Blvd. West
January 16, 2006
Laval, Quebec
H7L 4A8
Date of Revision:
July 12, 2022
Submission Control Number: 261533
WELLBUTRIN
®
XL is a registered trademark of the GlaxoSmithKline Group of companies
and is used
under license by Bausch Health Companies Inc.
_ _
_ _
_Pr_
_WELLBUTRIN_
_®_
_ XL, Bupropion Hydrochloride Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
11/2021
7 WARNING AND PRECAUTIONS
, Immune
11/2021
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
..............................................................................
5
4.1
Dosing Considerations
........................................................................................
5