TEGRETOL CR TABLET (EXTENDED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CARBAMAZEPINE

Commercializzato da:

NOVARTIS PHARMACEUTICALS CANADA INC

Codice ATC:

N03AF01

INN (Nome Internazionale):

CARBAMAZEPINE

Dosaggio:

400MG

Forma farmaceutica:

TABLET (EXTENDED-RELEASE)

Composizione:

CARBAMAZEPINE 400MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0108674004; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1997-05-05

Scheda tecnica

_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