TOPICORT GEL

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DESOXIMETASONE

Fáanlegur frá:

BAUSCH HEALTH, CANADA INC.

ATC númer:

D07AC03

INN (Alþjóðlegt nafn):

DESOXIMETASONE

Skammtar:

0.05%

Lyfjaform:

GEL

Samsetning:

DESOXIMETASONE 0.05%

Stjórnsýsluleið:

TOPICAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTI-INFLAMMATORY AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0112434002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2000-11-10

Vara einkenni

_Pr_
_TOPICORT _
_®_
_ Desoximetasone Cream, Gel and Ointment Product Monograph Page 1 of
23 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TOPICORT
®
Desoximetasone cream, USP
Cream 0.05% w/w and 0.25% w/w
Desoximetasone gel, USP
Gel 0.05% w/w
Desoximetasone ointment, USP
Ointment 0.25% w/w
Topical Corticosteroid
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
June 10, 1996
Date of Revision:
May 31, 2022
Submission Control Number: 260348
_ _
_Pr_
_TOPICORT _
_®_
_ Desoximetasone Cream, Gel and Ointment Product Monograph Page 2 of
23 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
05/2022
1 INDICATIONS, 1.1 Pediatrics
05/2022
1 INDICATIONS, 1.2 Geriatrics
05/2022
4 DOSAGE AND ADMINISTRATION
05/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
05/2022
7 WARNINGS AND PRECAUTIONS
05/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and
Metabolism
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
05/2022
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
4
DOSAGE AND ADMINISTRATION
.............................................................................
4
4.1