Summary for ARTG Entry:
RISPERIDONE WATSON risperidone 3mg film-coated tablet bottle
ARTG entry for
Medis Pharma Pty Ltd
PO Box 6127,North Sydney, NSW, 2059
ARTG Start Date
Drug Safety Evaluation Branch
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.
1. RISPERIDONE WATSON risperidone 3mg film-coated tablet bottle
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Risperidone Watson is indicated for the treatment of schizophrenia and related psychoses. Risperidone Watson is also indicated for the treatment of
behavioural disturbances in dementia. Risperidone Watson is indicated for the treatment of conduct and other disruptive disorders in children (over 5
years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression,
impulsivity and self-injurious behaviours) are prominent. (See Clinical Trials for maintenance data).
Additional Product information
Store below 25
Protect from Moisture
Protect from Light
Pack Size/Poison information
(S4) Prescription Only Medicine
1. Medicine component
Tablet, film coated
Route of Administration
Yellow, film-coated, oblong tablet engraved with "R", a breakline and "3" on
one side and a plain face on the other.
© 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
Produced at 29.11.2017 at 01:15:29 AEDT
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