AA-CLOZAPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOZAPINE

Available from:

AA PHARMA INC

ATC code:

N05AH02

INN (International Name):

CLOZAPINE

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

CLOZAPINE 25MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2003-08-07

Summary of Product characteristics

_AA-CLOZAPINE (Clozapine Tablets)_
_ _
_ _
_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
...........................................................................................................................
4
1.1 Pediatrics
...............................................................................................................................
5
1.2 Geriatrics
...............................................................................................................................
5
2 CONTRAINDICATIONS
..............................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.........................................................................
6
4 DOSAGE AND ADMINISTRATION
..............................................................................................
6
4.1 Dosing Considerations
...........................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
.......................................