DYSPORT AESTHETIC POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ABOBOTULINUMTOXINA

Dostępny od:

IPSEN BIOPHARMACEUTICALS CANADA INC

Kod ATC:

M03AX01

INN (International Nazwa):

BOTULINUM TOXIN

Dawkowanie:

300UNIT

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

ABOBOTULINUMTOXINA 300UNIT

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

3ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2017-01-03

Charakterystyka produktu

_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