TARO-MOMETASONE OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MOMETASONE FUROATE

Available from:

TARO PHARMACEUTICALS INC

ATC code:

D07AC13

INN (International Name):

MOMETASONE

Dosage:

0.1%

Pharmaceutical form:

OINTMENT

Composition:

MOMETASONE FUROATE 0.1%

Administration route:

TOPICAL

Units in package:

15/50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121732001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-02-10

Summary of Product characteristics

PRODUCT MONOGRAPH
TARO-MOMETASONE CREAM
PR
(Mometasone Furoate Cream, USP)
0.1% (w/w)
TARO-MOMETASONE OINTMENT
PR
(Mometasone Furoate Ointment, USP)
0.1% (w/w)
TARO-MOMETASONE LOTION
PR
(Mometasone Furoate Topical Solution, USP)
0.1% (w/w)
Topical Corticosteroid Therapy
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
October 9, 2018
Brampton, Ontario
L6T 1C1
Control Number: 220113
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
..................................................................................
2
INDICATIONS AND CLINICAL
USE........................................................................................
2
CONTRAINDICATIONS
.............................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................
3
ADVERSE REACTIONS
.............................................................................................................
6
DRUG INTERACTIONS
..............................................................................................................
8
DOSAGE AND ADMINISTRATION
..........................................................................................
8
OVERDOSAGE
............................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
10
STORAGE AND STABILITY
...................................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 11
PART II: SCIENTIFIC INFORMATION
.................................................................................
12
PHARMACEUTICAL INFORMATION
...................................................................................
12
CLINICAL
TRIALS..