NERISONE OILY CREAM

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DIFLUCORTOLONE VALERATE

Saatavilla:

GLAXOSMITHKLINE INC

ATC-koodi:

D07AC06

INN (Kansainvälinen yleisnimi):

DIFLUCORTOLONE

Annos:

0.1%

Lääkemuoto:

CREAM

Koostumus:

DIFLUCORTOLONE VALERATE 0.1%

Antoreitti:

TOPICAL

Kpl paketissa:

3G/30G/60G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTI-INFLAMMATORY AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2016-09-30

Valmisteyhteenveto

_ _
_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. _
_ _
_ _
_Page 2 of 19_
TABLE OF CONTENTS
_ _
_ _
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
_ _