AA-CLOZAPINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CLOZAPINE

Disponível em:

AA PHARMA INC

Código ATC:

N05AH02

DCI (Denominação Comum Internacional):

CLOZAPINE

Dosagem:

25MG

Forma farmacêutica:

TABLET

Composição:

CLOZAPINE 25MG

Via de administração:

ORAL

Unidades em pacote:

100/500

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:

2003-08-07

Características técnicas

_AA-CLOZAPINE (Clozapine Tablets)_
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AA-CLOZAPINE
Clozapine Tablets
Tablets, 25 mg, 50 mg, 100 mg and 200 mg, oral
USP
Antipsychotic Agent
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
AUG 19, 2016
Date of Revision:
APRIL 03, 2023
Submission Control Number: 269276
_AA-CLOZAPINE (Clozapine Tablets)_
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_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
04/2023
7 WARNINGS AND PRECAUTIONS, General, Anticholinergic Activity
04/2023
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
1 INDICATIONS
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4
1.1 Pediatrics
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5
1.2 Geriatrics
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5
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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6
4 DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
...........................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
.......................................