NERISONE OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIFLUCORTOLONE VALERATE

Available from:

GLAXOSMITHKLINE INC

ATC code:

D07AC06

INN (International Name):

DIFLUCORTOLONE

Dosage:

0.1%

Pharmaceutical form:

OINTMENT

Composition:

DIFLUCORTOLONE VALERATE 0.1%

Administration route:

TOPICAL

Units in package:

30G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0115864001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-11-03

Summary of Product characteristics

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_Page 1 of 20_
PRODUCT MONOGRAPH
PR
NERISONE
®
(DIFLUCORTOLONE VALERATE)
Cream 0.1% w/w
Oily Cream 0.1% w/w
Ointment 0.1% w/w
THERAPEUTIC CLASSIFICATION
TOPICAL CORTICOSTEROID
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Revision:
October 29, 2014
Submission Control No: 175615
_©2014 GlaxoSmithKline Inc., All Rights Reserved _
_®NERISONE is a trade mark of Bayer Schering Pharma
Aktiengesellschaft. _
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_Page 2 of 20_
TABLE OF CONTENTS
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PAGE
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
8
DRUG INTERACTIONS
...............................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 11
STORAGE AND STABILITY
.....................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 12
PART II: SCIENTIFIC INFORMATION
........................................................................
13
PHARMACEUTICAL INFORMATION
.....................................................................
13
REFERENCES
.............................................................................................................
16
PART III: CONSUMER INFORMATION
............