DYSPORT AESTHETIC POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ABOBOTULINUMTOXINA

Disponible desde:

IPSEN BIOPHARMACEUTICALS CANADA INC

Código ATC:

M03AX01

Designación común internacional (DCI):

BOTULINUM TOXIN

Dosis:

300UNIT

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

ABOBOTULINUMTOXINA 300UNIT

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

3ML

tipo de receta:

Prescription

Área terapéutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2017-01-03

Ficha técnica

_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