DOVONEX OINTMENT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CALCIPOTRIOL

Tersedia dari:

LEO PHARMA INC

Kode ATC:

D05AX02

INN (Nama Internasional):

CALCIPOTRIOL

Dosis:

50MCG

Bentuk farmasi:

OINTMENT

Komposisi:

CALCIPOTRIOL 50MCG

Rute administrasi :

TOPICAL

Unit dalam paket:

60G/120G

Jenis Resep:

Prescription

Area terapi:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Ringkasan produk:

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

Status otorisasi:

MARKETED

Tanggal Otorisasi:

1992-12-31

Karakteristik produk

_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
...............................................................