MYLAN-MIRTAZAPINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

MIRTAZAPINE

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

N06AX11

INN (Mezinárodní Name):

MIRTAZAPINE

Dávkování:

30MG

Léková forma:

TABLET

Složení:

MIRTAZAPINE 30MG

Podání:

ORAL

Jednotky v balení:

30/100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTIDEPRESSANTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2009-08-07

Charakteristika produktu

_MYLAN-MIRTAZAPINE (mirtazapine) _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
ANTI-DEPRESSANT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
AUG 16, 2004
Date of Revision:
October 27, 2022
Submission Control Number: 264393
_MYLAN-MIRTAZAPINE (mirtazapine) _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
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
........