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:

2020-07-09

Original market date: See footnote 1

1998-03-16

Product name:

AMETOP GEL 4%

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DIN:

02230575

Product Monograph/Veterinary Labelling:

Date: 2022-04-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

VALEO PHARMA INC
16667 Hymus Blvd.
Kirkland
Quebec
Canada H9H 4R9

Class:

Human

Dosage form(s):

Gel

Route(s) of administration:

Topical

Number of active ingredient(s):

1

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

84:08.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

D04AB06 TETRACAINE

Active ingredient group (AIG) number:See footnote5

0108851002

List of active ingredient(s)
Active ingredient(s) Strength
TETRACAINE (TETRACAINE HYDROCHLORIDE) 40 MG / G
Version 4.0.2
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