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Public Summary
Summary for ARTG Entry:
195414
ZATAMIL 0.1% LOTION mometasone furoate 0.1% w/w (1 mg/g) lotion bottle
ARTG entry for
Medicine Registered
Sponsor
Ego Pharmaceuticals Pty Ltd
Postal Address
21-31 Malcolm Road,BRAESIDE, VIC, 3195
Australia
ARTG Start Date
10/05/2012
Product category
Medicine
Status
Active
Approval area
Drug Safety Evaluation Branch
Conditions
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Products
1. ZATAMIL 0.1% LOTION mometasone furoate 0.1% w/w (1 mg/g) lotion bottle
Product Type
Effective date
Single Medicine Product
29/02/2016
Warnings
See Product Information and Consumer Medicine Information for this product
Specific Indications
For the short term (up to four continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as
psoriasis and atopic dermatitis.,ZATAMIL lotion is suitable for use in scalp psoriaris and application to other areas of the body.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Bottle
HDPE
30 Months
Store below 25
degrees Celsius
Neither child resistant
closure nor restricted
flow insert
Do not Refrigerate
Pack Size/Poison information
Pack Size
Poison Schedule
1 x 30 mL
(S4) Prescription Only Medicine
Components
1. ZATAMIL 0.1% LOTION mometasone furoate 0.1% w/w (1 mg/g) lotion bottle
Dosage Form
Lotion
Route of Administration
Topical
Visual Identification
Clear, colourless to straw coloured, slightly thickened solution
Active Ingredients
mometasone furoate
1 mg/g
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of 1
Produced at 17.06.2017 at 01:42:20 AEST
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Public Summary
Standard Indications