NOVO-OXCARBAZEPINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OXCARBAZEPINE

Disponible desde:

NOVOPHARM LIMITED

Código ATC:

N03AF02

Designación común internacional (DCI):

OXCARBAZEPINE

Dosis:

300MG

formulario farmacéutico:

TABLET

Composición:

OXCARBAZEPINE 300MG

Vía de administración:

ORAL

Unidades en paquete:

50/100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0140461002; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2018-07-24

Ficha técnica

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PRODUCT MONOGRAPH
PR
NOVO-OXCARBAZEPINE
(Oxcarbazepine)
150 mg, 300 mg and 600 mg Tablets
Antiepileptic
Novopharm Limited
DATE OF PREPARATION:
30 Novopharm Court
MAY 30, 2008
Toronto, Ontario
M1B 2K9
CONTROL NUMBER: 109545
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_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND
PRECAUTIONS.........................................................................................
4
ADVERSE
REACTIONS.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND
ADMINISTRATION.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 25
STORAGE AND
STABILITY.................................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 27
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL
INFORMATION.................................................................................
28
CLINICAL
TRIALS.................................................................................................................
29
DETAILED
PHARMACOLOGY............