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:
2022-08-31
Product name:
RYMTI
Description:
0.5 ML SINGLE-USE PRE-FILLED SYRINGE
DIN:
02530287
Product Monograph/Veterinary Labelling:
Date:
2022-08-31
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LUPIN PHARMA CANADA LIMITED
550-1111 Rue St-Charles Ouest
Longueuil
Quebec
Canada
J4K 5G4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
Biosimilar Biologic Drug:
Yes
American Hospital Formulary Service (AHFS): See footnote 3
92:36.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AB01 ETANERCEPT
Active ingredient group (AIG) number:See footnote5
0151564001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ETANERCEPT | 25 MG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.