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:
2021-03-01
Original market date: See footnote 1
2021-03-01
Product name:
INCRELEX
Description:
MULTI-DOSE VIAL
DIN:
02509733
Product Monograph/Veterinary Labelling:
Date:
2023-10-04
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
IPSEN BIOPHARMACEUTICALS CANADA INC
SUITE 500
5050 Satellite Drive
Mississauga
Ontario
Canada
L4W 0G1
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
68:30.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
H01AC03 MECASERMIN
Active ingredient group (AIG) number:See footnote5
0162642001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MECASERMIN | 40 MG / 4 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |