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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:

2013-12-09

Original market date: See footnote 1

2013-12-09

Product name:

UVADEX

Description:

TO BE ADMINSTERED VIA THE UVAR XTS OR THERAKOS CELLEX PHOTOPHERESIS SYSTEMS

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:

02406233

Product Monograph/Veterinary Labelling:

Date: 2013-05-03 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

THERAKOS INC
90 Washington Valley Road
Bedminster
New Jersey
United States  07921

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Extracorporeal

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

84:50.06   PIGMENTING AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

D05BA02  METHOXALEN, SYSTEMIC

Active ingredient group (AIG) number:See footnote 5

0107802003

List of active ingredient(s)
Active ingredient(s) Strength
METHOXSALEN 20 MCG / ML

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