NRA-CETIRIZINE TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-08-2022
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Active ingredient:
CETIRIZINE HYDROCHLORIDE
Available from:
NORA PHARMA INC
ATC code:
R06AE07
INN (International Name):
CETIRIZINE
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
CETIRIZINE HYDROCHLORIDE 20MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0122686003; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-08-30
Summary of Product characteristics
Page 1 of 32
PRODUCT MONOGRAPH
PR
NRA-CETIRIZINE TABLETS
CETIRIZINE HYDROCHLORIDE TABLETS
20 MG
Histamine H
1
Receptor Antagonist
Nora Pharma Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 24, 2022
Varennes, Quebec
J3X1P7
Control # 266426
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................
3
WARNINGS AND PRECAUTIONS
......................................................................................................
3
ADVERSE REACTIONS
........................................................................................................................
5
DRUG INTERACTIONS
.........................................................................................................................
7
DOSAGE AND ADMINISTRATION
.....................................................................................................
7
OVERDOSAGE
.......................................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
9
STORAGE AND STABILITY
..............................................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 10
PART II: SCIENTIFIC INFORMATION
..................................................................................................
12
PHARMACEUTICAL INFORMATION
....................................
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