Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2021-07-16
Original market date: See footnote 1
2012-07-04
Product name:
XEOMIN
DIN:
02371081
Product Monograph/Veterinary Labelling:
Date:
2023-10-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MERZ PHARMACEUTICALS GMBH
Eckenheimer Landstraße 100
Frankfurt
Hessen
Germany
60318
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intramuscular , Intraglandular
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
M03AX01 BOTULINUM TOXIN
Active ingredient group (AIG) number:See footnote5
0153613002
Active ingredient(s) | Strength |
---|---|
INCOBOTULINUMTOXINA | 50 UNIT / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.