PRIVA-SERTRALINE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Tilgængelig fra:

NORA PHARMA INC

ATC-kode:

N06AB06

INN (International Name):

SERTRALINE

Dosering:

25MG

Lægemiddelform:

CAPSULE

Sammensætning:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0123417003; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2022-07-26

Produktets egenskaber

_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
.................................................................................