INTUNIV XR TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GUANFACINE (GUANFACINE HYDROCHLORIDE)

Disponibil de la:

TAKEDA CANADA INC

Codul ATC:

C02AC02

INN (nume internaţional):

GUANFACINE

Dozare:

2MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

GUANFACINE (GUANFACINE HYDROCHLORIDE) 2MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CENTRAL ALPHA-AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0154470002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-12-04

Caracteristicilor produsului

_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 ........................................................................