TEGRETOL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CARBAMAZEPINE

Dostupno od:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC koda:

N03AF01

INN (International ime):

CARBAMAZEPINE

Doziranje:

200MG

Farmaceutski oblik:

TABLET

Sastav:

CARBAMAZEPINE 200MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTICONVULSANTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0108674001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

1997-06-05

Svojstava lijeka

_PR_
_TEGRETOL_
_®_
_ carbamazepine tablets, _
_PR_
_TEGRETOL_
_® _
_CR carbamazepine controlled-release tablets, _
_PR_
_TEGRETOL_
_®_
_ SUSPENSION carbamazepine suspension _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEGRETOL
®
carbamazepine tablets
Tablets, 200 mg, oral use
Novartis Standard
PR
TEGRETOL
® CR
carbamazepine controlled-release tablets
Controlled-Release Tablets, 200 mg and 400 mg, oral use
Novartis Standard
PR
TEGRETOL
® SUSPENSION
carbamazepine suspension
Suspension, 100 mg/5 mL, oral use
Novartis Standard
Anticonvulsant
For Symptomatic Relief of Trigeminal Neuralgia
Antimanic
ATC code: N03AF01
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec
H2Y 0C1
www.novartis.ca
Date of Initial Authorization :
Dec 31, 1969
Date of Revision:
Feb 26, 2024
Submission Control Number: 273178
TEGRETOL
is a registered trademark.
_PR_
_TEGRETOL_
_®_
_ carbamazepine tablets, _
_PR_
_TEGRETOL_
_®_
_ CR carbamazepine controlled-release tablets, _
_PR_
_TEGRETOL_
_®_
_ SUSPENSION carbamazepine suspension _
_Page 2 of 49 _
_ _
RECENT MAJOR LABEL CHANGES
None at the time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
5