APO-MIRTAZAPINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MIRTAZAPINE

Disponible depuis:

APOTEX INC

Code ATC:

N06AX11

DCI (Dénomination commune internationale):

MIRTAZAPINE

Dosage:

45MG

forme pharmaceutique:

TABLET

Composition:

MIRTAZAPINE 45MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTIDEPRESSANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0143928003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-10-03

Résumé des caractéristiques du produit

_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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_Page 1 of 44 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
USP
Antidepressant
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 03, 2006
Date of Revision:
January 31, 2022
Submission Control Number: 257508
_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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_Page 2 of 44 _
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RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
01/2022
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
..................................................................................................................
4
1.1
PEDIATRICS
...................................................................................................................
4
1.2
GERIATRICS
...................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING CONSIDERATIONS
...........................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
................................................... 5
4.3
ADMINISTRATION
.........................................................................................................
6
4.4
RECONSTITUTION
.........................................................................................................
6
4.5
MISSED DOSE
................................................................................................................
6
5
OVERDOSAGE
.....................................................