GEN-CLOZAPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOZAPINE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

N05AH02

INN (International Name):

CLOZAPINE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

CLOZAPINE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2009-08-07

Summary of Product characteristics

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
11
1
INDICATIONS..............................................................................................................
11
1.1
Pediatrics..........................................................................................................
12
1.2
Geriatrics
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12
2
CONTRAINDICATIONS
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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
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