DYSPORT AESTHETIC POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ABOBOTULINUMTOXINA

Предлага се от:

IPSEN BIOPHARMACEUTICALS CANADA INC

АТС код:

M03AX01

INN (Международно Name):

BOTULINUM TOXIN

дозиране:

300UNIT

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

ABOBOTULINUMTOXINA 300UNIT

Начин на приложение:

INTRAMUSCULAR

Броя в опаковка:

3ML

Вид предписание :

Prescription

Терапевтична област:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0153614001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2017-01-03

Данни за продукта

_Dysport Aesthetic_
_®_
_ _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DYSPORT AESTHETIC
®
abobotulinumtoxinA
Sterile lyophilized powder for solution for injection
300 Units per vial
Neuromuscular Blocking Agent
Ipsen Biopharmaceuticals Canada Inc.
5050 Satellite Drive, Suite 500
Mississauga, ON
L4W 0G1
Date of Initial Authorization:
FEB 19, 2013
Date of Revision:
SEP 5, 2023
Distributed by:
Galderma Canada Inc.
55 Commerce Valley Drive West
Thornhill, ON L3T 7V9
Submission Control Number: 273398
_ _
_Dysport Aesthetic_
_®_
_ (abobotulinumtoxinA) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
03/2022
3 Serious Warnings and Precautions Box
08/2023
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
....................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
..........................................................................................
5
4.2
Recommended Dose and Dosage Ad