XEOMIN COSMETIC POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

INCOBOTULINUMTOXINA

Доступна з:

MERZ PHARMACEUTICALS GMBH

Код атс:

M03AX01

ІПН (Міжнародна Ім'я):

BOTULINUM TOXIN

Дозування:

100UNIT

Фармацевтична форма:

POWDER FOR SOLUTION

Склад:

INCOBOTULINUMTOXINA 100UNIT

Адміністрація маршрут:

INTRAMUSCULAR

Одиниць в упаковці:

1/2/3/6 VIALS

Тип рецепту:

Prescription

Терапевтична области:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0153613001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2012-04-12

Характеристики продукта

_XEOMIN COSMETIC_
_®_
_ (incobotulinumtoxinA) - Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XEOMIN COSMETIC
®
incobotulinumtoxinA
Clostridium Botulinum Neurotoxin Type A (150 kD), free from complexing
proteins
Powder for solution for injection
100 units per vial
Intramuscular injection
Pharmaceutical Standard: House
Muscle relaxant, peripherally acting agent
Manufactured by:
Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt/Main
Germany
http://www.merz.com/company/merz_pharmaceuticals/
Imported and distributed by:
Merz Pharma Canada Ltd.
5515 North Service Road, Ste 202
Burlington, ON L7L 6G4
Date of Initial Authorization:
April 12, 2012
Date of Revision: October 3, 2023
Submission Control Number: 274814
_ _
_XEOMIN COSMETIC_
_®_
_ (incobotulinumtoxinA) - Product Monograph _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
2. CONTRAINDICATIONS
04/2023
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2023
4. DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
01/2023
7. WARNINGS AND PRECAUTIONS, DRIVING AND OPERATING MACHINERY
01/2023
TABLE OF CONTENTS
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 P