AA-CLOZAPINE TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CLOZAPINE

Disponibbli minn:

AA PHARMA INC

Kodiċi ATC:

N05AH02

INN (Isem Internazzjonali):

CLOZAPINE

Dożaġġ:

200MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

CLOZAPINE 200MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ATYPICAL ANTIPSYCHOTICS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0122583004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2016-11-08

Karatteristiċi tal-prodott

_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)_
_ _
_ _
_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
..............................................................................................
6
4.1 Dosing Considerations
...........................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
.......................................