CIPRALEX MELTZ TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-06-2016
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Active ingredient:
ESCITALOPRAM
Available from:
LUNDBECK CANADA INC
ATC code:
N06AB10
INN (International Name):
ESCITALOPRAM
Dosage:
20MG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
Composition:
ESCITALOPRAM 20MG
Administration route:
ORAL
Units in package:
30/60
Prescription type:
Prescription
Therapeutic area:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0150435004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-15
Summary of Product characteristics
PRODUCT
MONOGRAPH
PR
CIPRALEX
Escitalopram Oxalate Tablets
5, 10, 15, 20 mg as escitalopram
PR
CIPRALEX MELTZ
Escitalopram Orodispersible Tablets
10, 20 mg as escitalopram
ANTIDEPRESSANT / ANXIOLYTIC / ANTIOBSESSIONAL
Lundbeck Canada Inc.
DATE OF REVISION:
1000 De La Gauchetière Street West
June 9, 2016
Suite 500
Montreal (Quebec), Canada
H3B 4W5
SUBMISSION CONTROL NO: 192637
_Page 2 of 69 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
4
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
31
DOSAGE AND ADMINISTRATION
.....................................................................................
37
OVERDOSAGE
......................................................................................................................
40
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 41
STORAGE AND STABILITY
.................................................................................................
43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 43
PART II: SCIENTIFIC INFORMATION
...............................................................................
45
PHARMACEUTICAL INFORMATION
.................................................................................
45
CLI
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