GEN-CLOZAPINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLOZAPINE

Disponible des:

MYLAN PHARMACEUTICALS ULC

Codi ATC:

N05AH02

Designació comuna 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:

Estat d'Autorització:

APPROVED

Data d'autorització:

2009-08-07

Fitxa tècnica

_Page 1 of 47_
_Mylan Pharmaceuticals ULC _
_June 7, 2022 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GEN-CLOZAPINE
Clozapine Tablets
Tablets, 25 mg, 50 mg, 100 mg, 200 mg, Oral
Mylan Std.
Antipsychotic Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario M8Z 2S6
Date of Initial Authorization:
February 17, 2014
Date of Revision:
July 18, 2022
Submission Control No: 261515
_GEN-CLOZAPINE (clozapine) Product Monograph _
_June 7, 2022 _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
07/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.......................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
11
1
INDICATIONS..............................................................................................................
11
1.1
Pediatrics..........................................................................................................
12
1.2
Geriatrics
..........................................................................................................
12
2
CONTRAINDICATIONS
...............................................................................................
12
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 13
4
DOSAGE AND ADMINISTRATION
..............................................................................
13
4.1
Dosing Considerations
......................................................................................
13
4.2
Recommended Dose and Dosage
Adjustment................................................... 15
4.4
Administration
............................................