XEOMIN POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INCOBOTULINUMTOXINA

Available from:

MERZ PHARMACEUTICALS GMBH

ATC code:

M03AX01

INN (International Name):

BOTULINUM TOXIN

Dosage:

100UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

INCOBOTULINUMTOXINA 100UNIT

Administration route:

INTRAGLANDULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2009-03-13

Summary of Product characteristics

_Xeomin_
_®_
_ (incobotulinumtoxinA) - Product Monograph _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XEOMIN
®
incobotulinumtoxinA for injection
Clostridium Botulinum Neurotoxin Type A (150 kD), free from complexing
proteins
50 and 100 units per vial
Intramuscular or intraglandular 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:
March 13, 2009
Date of Revision: October 3, 2023
Submission Control Number: 274814
_Xeomin_
_®_
_ (incobotulinumtoxinA) - Product Monograph _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Chronic Sialorrhea in Pediatric Patients
09/2022
1 INDICATIONS, Spasticity of the Upper Limb
03/2022
1.1 PEDIATRICS, Chronic Sialorrhea in Pediatric Patients
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment,
Chronic Sialorrhea in Pediatric Patients
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment,
Spasticity of the Upper Limb
03/2022
4 DOSAGE AND ADMINISTRATION,4.4, Administration, Chronic Sialorrhea
(pediatrics)
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatric Sialorrhea
09/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
.....................................................................