XEOMIN COSMETIC 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:

INTRAMUSCULAR

Units in package:

1/2/3/6 VIALS

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-04-12

Summary of Product characteristics

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1.
INDICATIONS
................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2.
CONTRAINDICATIONS
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4
3.
SERIOUS WARNINGS AND P