TARO-CALCIPOTRIOL / BETAMETHASONE GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE); BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

Available from:

TARO PHARMACEUTICALS 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/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0252270002; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-02-10

Summary of Product characteristics

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PRODUCT MONOGRAPH
PR
TARO-CALCIPOTRIOL / BETAMETHASONE 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
Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
February 09, 2022
Brampton, ON
L6T 1C1
Submission
Control No.: 253642
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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
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION............................