Țară: Canada
Limbă: engleză
Sursă: Health Canada
GUANFACINE (GUANFACINE HYDROCHLORIDE)
TAKEDA CANADA INC
C02AC02
GUANFACINE
1MG
TABLET (EXTENDED-RELEASE)
GUANFACINE (GUANFACINE HYDROCHLORIDE) 1MG
ORAL
15G/50G
Prescription
CENTRAL ALPHA-AGONISTS
Active ingredient group (AIG) number: 0154470001; AHFS:
APPROVED
2020-12-04
_INTUNIV XR_ _®_ _ (guanfacine hydrochloride extended-release tablets) _ _Template Date: June 2017 _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR INTUNIV XR ® guanfacine hydrochloride extended-release tablets Extended-release tablets, 1 mg, 2 mg, 3 mg, 4 mg Oral selective alpha 2A -adrenergic receptor agonist Takeda Canada Inc. 22 Adelaide Street. West, Suite 3800 Toronto, Ontario, M5H 4E3 Date of Initial Approval: Jul 05, 2013 Date of Revision: Dec 03, 2020 Submission Control No: 240952 INTUNIV XR ® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc. Takeda TM and the Takeda Logo ® are trademarks of Takeda Pharmaceutical Company Limited, used under license. _ _ _INTUNIV XR_ _®_ _ (guanfacine hydrochloride extended-release tablets) _ _Template Date: June 2017 _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES The company name has changed from ‘Shire Pharma Canada ULC’ to ‘Takeda Canada Inc.’ 11/2020 _Sections or subsections that are not applicable at the time of authorization are not listed._ TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................2 TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4 1 INDICATIONS ....................................................................................................................4 1.1 Pediatrics ....................................................................................................................5 1.2 Adults .........................................................................................................................5 1.3 Geriatrics ....................................................................................................................5 2 CONTRAINDICATIONS ........................................................................ Citiți documentul complet