GEN-CLOZAPINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CLOZAPINE

Disponível em:

MYLAN PHARMACEUTICALS ULC

Código ATC:

N05AH02

DCI (Denominação Comum Internacional):

CLOZAPINE

Dosagem:

25MG

Forma farmacêutica:

TABLET

Composição:

CLOZAPINE 25MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

ATYPICAL ANTIPSYCHOTICS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2009-08-07

Características técnicas

_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
............................................