SANDOZ CLOZAPINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-03-2020
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Active ingredient:
CLOZAPINE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
N05AH02
INN (International Name):
CLOZAPINE
Dosage:
25MG
Pharmaceutical form:
TABLET
Composition:
CLOZAPINE 25MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ATYPICAL ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0122583001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-07-25
Summary of Product characteristics
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_Sandoz Clozapine Page 1 of 53_
PRODUCT MONOGRAPH
PR
SANDOZ CLOZAPINE
Clozapine Tablets
25 mg and 100 mg tablets
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
March 20, 2020
Boucherville, QC, Canada
J4B 1E6
Control No.: 237094
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_Sandoz Clozapine Page 2 of 53_
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
.................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
25
DOSAGE AND ADMINISTRATION
..............................................................................
27
OVERDOSAGE
................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
..........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL
INFORMATION..........................................................................
33
CLINICAL TRIALS
..........................................................................................................
34
DETAILED PHARMACOLOGY
..................................................
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