Country: Canada
Language: English
Source: Health Canada
CLOZAPINE
AURO PHARMA INC
N05AH02
CLOZAPINE
200MG
TABLET
CLOZAPINE 200MG
ORAL
100/500
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0122583004; AHFS:
APPROVED
2016-05-26
_AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 1 of 52 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-CLOZAPINE Clozapine Tablets, USP 25 mg, 50 mg, 100 mg and 200 mg Antipsychotic Agent AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, CANADA. Date of Initial Authorization: April 06, 2016 Date of Revision: September 28, 2022 Submission Control No.: 266744 _AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 2 of 52 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 09/2022 7 WARNINGS AND PRECAUTIONS, General, Anticholinergic Activity 03/2022 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 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................ 4 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 ............................................................................................ 7 4.1 Dosing Considerations .............................................................................................. 7 4.2 Recommended Dose and Dos Read the complete document