ESCITALOPRAM TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Available from:

NORA PHARMA INC

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Administration route:

ORAL

Units in package:

10/100/500

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:

2023-07-28

Summary of Product characteristics

_ESCITALOPRAM Tablets _
_Page 1 of 53 _
PRODUCT MONOGRAPH
PR
ESCITALOPRAM TABLETS
Escitalopram Oxalate Tablets
10 and 20 mg escitalopram (as escitalopram oxalate)
Manufacturer’s Standard
ANTIDEPRESSANT / ANTIOBSESSIONAL
NORA PHARMA INC.
1565, Lionel-Boulet Boul.
Varennes, Québec
J3X 1P7
Control #: 263886
Date of
Preparation:
June 2,
2022
_ESCITALOPRAM Tablets _
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG
INTERACTIONS..........................................................................................................
23
DOSAGE AND
ADMINISTRATION......................................................................................
29
OVERDOSAGE
........................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
32
STORAGE AND STABILITY
.................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 33
PART II: SCIENTIFIC INFORMATION
..........................................................................................
35
PHARMACEUTICAL INFORMATION
.................................................................................