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:
2017-09-06
Original market date: See footnote 1
2017-09-06
Product name:
DEFITELIO
Description:
MEDICINAL INGREDIENT ALSO CALLED 'DEFIBROTIDE SODIUM'
DIN:
02465981
Product Monograph/Veterinary Labelling:
Date:
2019-12-04
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JAZZ PHARMACEUTICALS IRELAND LIMITED
5th Floor, Waterloo Exchange, Waterloo Rd.
Dublin
Dublin
Ireland
D04 E5W7
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
20:12.20
Anatomical Therapeutic Chemical (ATC): See footnote 4
B01AX01 DEFIBROTIDE
Active ingredient group (AIG) number:See footnote5
0159250001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DEFIBROTIDE | 80 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |