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:
Approved
Current status date:
2025-02-28
Product name:
MYTOLAC
Description:
SINGLE USE PRE-FILLED SYRINGE
DIN:
02555867
Product Monograph/Veterinary Labelling:
Date:
2025-02-28
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ADVANZ PHARMA CANADA INC.
300
4263 Sherwoodtowne Blvd.
Mississauga
Ontario
Canada
L4Z 1Y5
Class:
Human
Dosage form(s):
Solution (Extended Release)
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:29.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
H01CB03 LANREOTIDE
Active ingredient group (AIG) number:See footnote5
0151653006
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LANREOTIDE (LANREOTIDE ACETATE) | 60 MG / SYR |