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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

12:16.04.04   Non-Selective Alfa-Adrenergic Blocking Agents

Anatomical Therapeutic Chemical (ATC): See footnote 4

V03AB36  PHENTOLAMINE

Active ingredient group (AIG) number:See footnote 5

0107611003

List of active ingredient(s)
Active ingredient(s) Strength
PHENTOLAMINE MESYLATE 0.4 MG / 1.7 ML

Application information

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