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:
2018-01-03
Original market date: See footnote 1
2007-08-03
Product name:
XYREM
DIN:
02268272
Product Monograph/Veterinary Labelling:
Date:
2022-09-29
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:
Oral
Number of active ingredient(s):
1
Schedule(s):
Schedule G (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07XX04 HYDROXYBUTYRIC ACID
Active ingredient group (AIG) number:See footnote5
0151061001
| Active ingredient(s) | Strength |
|---|---|
| SODIUM OXYBATE | 500 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 Consent |