DOVOBET GEL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-02-2020
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Active ingredient:
CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE); BETAMETHASONE (BETAMETHASONE DIPROPIONATE)
Available from:
LEO PHARMA INC
ATC code:
D05AX52
INN (International Name):
CALCIPOTRIOL, COMBINATIONS
Dosage:
50MCG; 0.5MG
Pharmaceutical form:
GEL
Composition:
CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE) 50MCG; BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.5MG
Administration route:
TOPICAL
Units in package:
15G/30G/60G
Prescription type:
Prescription
Therapeutic area:
ANTI-INFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0252270001; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-11-06
Summary of Product characteristics
_DOVOBET® Gel Product Monograph, version 5.0 _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
DOVOBET® GEL
calcipotriol and betamethasone dipropionate gel
50 mcg/g calcipotriol (as monohydrate) and
0.5 mg/g betamethasone (as dipropionate) gel
Topical Antipsoriatic Agent
Vitamin D Analogue / Corticosteroid
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.ca
Date of Revision:
February 25, 2020
Submission Control No.: 234060
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
_DOVOBET® Gel Product Monograph, version 5.0 _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATI
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