SANDOZ CLOZAPINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CLOZAPINE

Disponible desde:

SANDOZ CANADA INCORPORATED

Código ATC:

N05AH02

Designación común internacional (DCI):

CLOZAPINE

Dosis:

25MG

formulario farmacéutico:

TABLET

Composición:

CLOZAPINE 25MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ATYPICAL ANTIPSYCHOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0122583001; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2022-07-25

Ficha técnica

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PRODUCT MONOGRAPH
PR
SANDOZ CLOZAPINE
Clozapine Tablets
25 mg and 100 mg tablets
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
March 20, 2020
Boucherville, QC, Canada
J4B 1E6
Control No.: 237094
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_Sandoz Clozapine Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
25
DOSAGE AND ADMINISTRATION
..............................................................................
27
OVERDOSAGE
................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
..........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL
INFORMATION..........................................................................
33
CLINICAL TRIALS
..........................................................................................................
34
DETAILED PHARMACOLOGY
..................................................