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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:

2020-04-16

Original market date: See footnote 1

2010-06-15

Product name:

FINACEA

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:

02270811

Product Monograph/Veterinary Labelling:

Date: 2019-09-18 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

LEO PHARMA INC
123 Commerce Valley Drive East, Suite 400
Thornhill
Ontario
Canada  L3T 7W8

Class: 

Human

Dosage form(s):

Gel

Route(s) of administration:

Topical

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

84:92.00   MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

D10AX03  AZELAIC ACID

Active ingredient group (AIG) number:See footnote 5

0126787002

List of active ingredient(s)
Active ingredient(s) Strength
AZELAIC ACID 15 % / W/W

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