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:
2023-05-18
Original market date: See footnote 1
2021-02-16
Product name:
HULIO
Description:
SINGLE- DOSE PREFILLED SYRINGES
DIN:
02502399
Product Monograph/Veterinary Labelling:
Date:
2023-07-20
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BIOSIMILAR COLLABORATIONS IRELAND LIMITED
UNIT 35/36
Grange Parade, Baldoyle Industrial Estate, Dublin 13
Dublin
--
Ireland
D13R20R
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
L04AB04 ADALIMUMAB
Active ingredient group (AIG) number:See footnote5
0150364003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ADALIMUMAB | 40 MG / 0.8 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |