DOVONEX OINTMENT

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:

OINTMENT

Composition:

CALCIPOTRIOL 50MCG

Administration route:

TOPICAL

Units in package:

60G/120G

Prescription type:

Prescription

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

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

Authorization status:

MARKETED

Authorization date:

1992-12-31

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
_DOVONEX® (calcipotriol) _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DOVONEX®
calcipotriol
Ointment, 50mcg/g, Topical
ATC Code: D05AX02
Topical Non-Steroidal Antipsoriatic Agent
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.ca.
Date of Initial Authorization:
Dec 31,1992
Date of Revision:
December 13, 2021
Submission Control Number: 252165
® Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, L3T 7W8
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_DOVONEX® (calcipotriol) _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
1. INDICATIONS, 1.1 Pediatrics
12/2021
2. CONTRAINDICATIONS
12/2021
4. DOSAGE AND ADMINISTRATION, 3.1 Dosing considerations, 3.2
Recommended Dose and Dosage Adjustment, 3.3 Administration
12/2021
7. WARNINGS AND PRECAUTIONS, 6.1 Special Populations
12/2021
TABLE OF CONTENTS
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
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
...............................................................