GD-MIRTAZAPINE OD TABLET (ORALLY DISINTEGRATING)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MIRTAZAPINE

Disponible depuis:

GENMED A DIVISION OF PFIZER CANADA ULC

Code ATC:

N06AX11

DCI (Dénomination commune internationale):

MIRTAZAPINE

Dosage:

30MG

forme pharmaceutique:

TABLET (ORALLY DISINTEGRATING)

Composition:

MIRTAZAPINE 30MG

Mode d'administration:

ORAL

Unités en paquet:

5X6

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTIDEPRESSANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0143928002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2014-12-08

Résumé des caractéristiques du produit

_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
GD-MIRTAZAPINE OD*
(Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg and 45 mg)
Antidepressant
GenMed, a division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
*GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
© Pfizer Canada Inc., 2012
Submission control No.: 153710 Date of Revision:
March 29, 2012
_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE
REACTIONS..........................................................................................................
9
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 20
STORAGE AND
STABILITY................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................