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:
2021-09-09
Original market date: See footnote 1
2021-09-09
Product name:
ULTOMIRIS
Description:
SINGLE USE, 300MG/30ML
DIN:
02491559
Product Monograph/Veterinary Labelling:
Date:
2023-10-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ALEXION PHARMA GMBH
Neuhofstrasse 34
Baar
--
Switzerland
6340
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
90:20.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AJ02 RAVULIZUMAB
Active ingredient group (AIG) number:See footnote5
0161710001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| RAVULIZUMAB | 10 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Healthcare Professional Education |
| Patient Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Registry |
| Observational Studies |