UVADEX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHOXSALEN

Available from:

THERAKOS INC

ATC code:

D05BA02

INN (International Name):

METHOXALEN, SYSTEMIC

Dosage:

20MCG

Pharmaceutical form:

SOLUTION

Composition:

METHOXSALEN 20MCG

Administration route:

EXTRACORPOREAL

Units in package:

12X10ML

Prescription type:

Prescription

Therapeutic area:

PIGMENTING AGENTS

Product summary:

Active ingredient group (AIG) number: 0107802003; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-05-09

Summary of Product characteristics

_UVADEX (methoxsalen) Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
UVADEX
®
Methoxsalen
Sterile Solution, 20 mcg/mL, for extracorporeal administration
Antineoplastic Agent, ATC code: D05BA02
For use with the THERAKOS
®
CELLEX
®
Photopheresis System
Therakos, Inc.
90 Washington Valley Road
Bedminster, NJ 07921
USA
Imported by:
C.R.I.
Unit #400, 3455 North Service Road
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
MAY 9, 2013
Date of Revision:
AUG 30, 2021
Submission Control Number: 250515
_UVADEX (methoxsalen) Product Monograph _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Driving and
Operating Machinery, Carcinogenicity and Mutagenesis
08/2021
7 WARNINGS AND PRECAUTIONS, General, Carcinogenicity
and Mutagenesis
08/2021
TABLE OF CONTENTS
_Sections or subsections that are not applicable at the time of
authorization are not listed._
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerat