Страна: Канада
мова: англійська
Джерело: Health Canada
BUPROPION HYDROCHLORIDE
BAUSCH HEALTH, CANADA INC.
N06AX12
BUPROPION
150MG
TABLET (EXTENDED-RELEASE)
BUPROPION HYDROCHLORIDE 150MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0131140003; AHFS:
APPROVED
2021-06-11
_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 Прочитайте повний документ