NERISONE OILY CREAM

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:

CREAM

Composition:

DIFLUCORTOLONE VALERATE 0.1%

Administration route:

TOPICAL

Units in package:

3G/30G/60G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-09-30

Summary of Product characteristics

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_Page 1 of 19_
PRODUCT MONOGRAPH
PR
NERISONE
®
(DIFLUCORTOLONE VALERATE)
Oily Cream 0.1% w/w
GSK Standard
Topical Corticosteroid
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
January 26, 2017
Submission Control No: 200095
_©2017 GSK Inc., All Rights Reserved _
_NERISONE is a trademark of Bayer Schering Pharma Aktiengesellschaft,
used under license by GSK Inc. _
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_Page 2 of 19_
TABLE OF CONTENTS
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PAGE
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
...............................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 10
STORAGE AND STABILITY
.....................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 11
PART II: SCIENTIFIC INFORMATION
........................................................................
13
PHARMACEUTICAL INFORMATION
.....................................................................
13
REFERENCES
.............................................................................................................
16
PART III: CONSUMER INFORMATION
......................................................................
17
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