MYLAN-MIRTAZAPINE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

MIRTAZAPINE

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

N06AX11

INN（国際名）:

MIRTAZAPINE

投薬量:

45MG

医薬品形態:

TABLET

構図:

MIRTAZAPINE 45MG

投与経路:

ORAL

パッケージ内のユニット:

30/100

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTIDEPRESSANTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2009-08-07

製品の特徴

_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
........