DOVONEX SOLUTION - TOP 50MCG/ML

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCIPOTRIOL

Available from:

LEO PHARMA INC

ATC code:

D05AX02

INN (International Name):

CALCIPOTRIOL

Dosage:

50MCG

Pharmaceutical form:

SOLUTION

Composition:

CALCIPOTRIOL 50MCG

Administration route:

TOPICAL

Units in package:

60ML

Prescription type:

Prescription

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

Active ingredient group (AIG) number: 0123661001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-03-16

Summary of Product characteristics

PRODUCT MONOGRAPH
PR DOVONEX®
CALCIPOTRIOL
CREAM AND OINTMENT, 50 MCG/G
SCALP SOLUTION, 50 MCG/ML
TOPICAL NON-STEROIDAL
ANTIPSORIATIC AGENT
LEO PHARMA INC.
THORNHILL, ONTARIO
L3T 7W8
WWW.LEO-PHARMA.COM/CANADA
Date of Preparation:
October 27, 1992
Date of Revision:
OCTOBER 9, 2007
Submission Control No: 109621
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
_ _
_DOVONEX® (calcipotriol) Product Monograph, version 2.0 _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND
ADMINISTRATION................................................................................7
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND
STABILITY..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL
INFORMATION..........................................................................13
CLINICAL
TRIALS.......