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:
2026-02-24
Original market date: See footnote 1
2026-02-24
Product name:
NEMLUVIO
Description:
SINGLE-USE PRE-FILLED DUAL CHAMBER PEN
DIN:
02563673
Product Monograph/Veterinary Labelling:
Date:
2025-12-18
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GALDERMA CANADA INC.
161 Bay Street, Suite 3900
Toronto
Ontario
Canada
M5J 2S1
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
SCHEDULE D , PRESCRIPTION
American Hospital Formulary Service (AHFS): See footnote 3
84:06.28
Anatomical Therapeutic Chemical (ATC): See footnote 4
D11AH12 NEMOLIZUMAB
Active ingredient group (AIG) number:See footnote5
0167953001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| NEMOLIZUMAB | 30 MG / 0.49 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |