CLOZAPINE TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-10-2018
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Active ingredient:
CLOZAPINE
Available from:
INNOMAR STRATEGIES INC.
ATC code:
N05AH02
INN (International Name):
CLOZAPINE
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
CLOZAPINE 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ATYPICAL ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0122583002; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-10-11
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Clozapine Tablets
25 mg and 100 mg
House Standard
Antipsychotic Agent
Innomar Strategies Inc. DATE OF REVISION:
3470 Superior Court October 11, 2018
Oakville, Ontario
L6L 0C4
Control No.: 219938
_Product Monograph _
_August 2018 _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...............................................................................................
21
DRUG INTERACTIONS
................................................................................................
28
DOSAGE AND ADMINISTRATION
...............................................................................
29
OVERDOSAGE
............................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 35
STORAGE AND STABILITY
.........................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 36
PART II: SCIENTIFIC INFORMATION
....................................................................................
38
PHARMACEUTICAL INFORMATION
...........................................................................
38
CLINICAL TRIALS
........................................................................................................
39
DETAILED PHARMACOLOGY
...........................
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