AA-CLOZAPINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CLOZAPINE

Commercializzato da:

AA PHARMA INC

Codice ATC:

N05AH02

INN (Nome Internazionale):

CLOZAPINE

Dosaggio:

50MG

Forma farmaceutica:

TABLET

Composizione:

CLOZAPINE 50MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

ATYPICAL ANTIPSYCHOTICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0122583003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-11-08

Scheda tecnica

_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
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2
TABLE OF CONTENTS
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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
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6
4.2 Recommended Dose and Dosage Adjustment
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