Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
Commercialisé
Current status date:
2023-10-04
Original market date: See footnote 1
2023-10-04
Product name:
XYWAV
Description:
0.5 G/ML DE SELS AU TOTAL
DIN:
02538237
Product Monograph/Veterinary Labelling:
Date:
2024-07-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JAZZ PHARMACEUTICALS IRELAND LIMITED
5th Floor, Waterloo Exchange, Waterloo Rd.
Dublin
DUBLIN
IRLANDE
D04 E5W7
Class:
Humain
Dosage form(s):
Solution
Route(s) of administration:
Orale
Number of active ingredient(s):
4
Schedule(s):
Annexe G (LRCDAS I)
American Hospital Formulary Service (AHFS): See footnote 3
28:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07XX04 (FR) HYDROXYBUTYRIC ACID
Active ingredient group (AIG) number:See footnote5
0464702001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| Oxybate de calcium | 0.234 G / ML |
| Oxybate de magnésium | 0.096 G / ML |
| Oxybate de potassium | 0.13 G / ML |
| Oxybate de sodium | 0.04 G / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Programme de distribution contrôlée |
| Matériel éducatif à l'intention des patients |
| Matériel éducatif à l'intention des professionels de la santé |
| Formulaire de consentement - patient |