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:
2014-09-17
Original market date: See footnote 1
2014-09-17
Product name:
ORAVERSE
Description:
FOR INTRAORAL SUBMUCOSAL INJECTION ONLY
DIN:
02421666
Product Monograph/Veterinary Labelling:
Date:
2014-02-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SEPTODONT
58 Rue Du Pont De Creteil
St-Maur-Des-Fosses
Val-De-Marne
France
94107
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Submucosal
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
12:16.04.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
V03AB36 PHENTOLAMINE
Active ingredient group (AIG) number:See footnote5
0107611003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| PHENTOLAMINE MESYLATE | 0.4 MG / 1.7 ML |