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:
2023-02-15
Original market date: See footnote 1
2023-02-15
Product name:
EMPAVELI
Description:
SINGLE-USE VIAL
DIN:
02533294
Product Monograph/Veterinary Labelling:
Date:
2022-12-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
Tomtebodav 23a
Stockholm
--
Sweden
11276
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
90:20.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AJ03 PEGCETACOPLAN
Active ingredient group (AIG) number:See footnote5
0164341001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| PEGCETACOPLAN | 1080 MG / 20 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 |