TEVA-CHLORPROMAZINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-12-2012
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Active ingredient:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE)
Available from:
TEVA CANADA LIMITED
ATC code:
N05AA01
INN (International Name):
CHLORPROMAZINE
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) 100MG
Administration route:
ORAL
Units in package:
100/500/1000
Prescription type:
Prescription
Therapeutic area:
PHENOTHIAZINES
Product summary:
Active ingredient group (AIG) number: 0106167002; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-03-08
Summary of Product characteristics
_TEVA-CHLORPROMAZINE _
_ _
_Product Monograph _
_Page 1 of 18_
PRODUCT MONOGRAPH
PR
TEVA-CHLORPROMAZINE
Chlorpromazine Hydrochloride Tablets
25 mg, 50 mg and 100 mg
Teva Standard
Antipsychotic–Antiemetic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Preparation:
December 11, 2012
SUBMISSION CONTROL NO: 154593
_TEVA-CHLORPROMAZINE _
_ _
_Product Monograph _
_Page 2 of 18_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
REFERENCES
..............................................................
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