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Monday, 3 April 2000
Page: 15096


Mr Price asked the Minister for Health and Aged Care, upon notice, on 23 November 1999:

(1) Has naltrexone been approved in the USA for drug rehabilitation; if so, when was it approved.

(2) Which countries have approved naltrexone for use.


Dr Wooldridge (Minister for Health and Aged Care) —The answer to the honourable member's question is as follows:

(1) ReVia, containing the active ingredient naltrexone, was first approved by the Food and Drug Administration, USA, on the 20 November 1984 for the treatment of opioid addiction and on the 30 December 1994 for the treatment of alcohol dependence.ReVia is not approved for ultra rapid opiate detoxification programs in the USA.

(2) Australia approved the use of naltrexone for treating opiate addiction and alcohol dependence in January 1999. Twenty-eight other countries have also approved naltrexone for these indications, including the U.S.A., France, Ireland, Luxembourg, Italy, Israel, Spain, Denmark, Netherlands, Oman, Austria, Pakistan, Brazil, Bahrain, Finland, Canada, Egypt, Colombia, Peru, Kuwait, Taiwan, Argentina, Bolivia, Eire, Hungary, Korea, Lithuania and Thailand.

13 countries had registered naltrexone for the treatment of opiate addiction only. These are U.K., Belgium, Germany, Poland, Singapore, Portugal, Switzerland, Malaysia, Greece, Saudi Arabia, Hong Kong, New Zealand, and U.A.E. Of these, Greece, New Zealand, Poland, Portugal and U.A.E. had marketing approvals pending for the treatment of alcohol dependence.

13 countries had marketing approvals pending for the treatment of opiate addiction and alcohol addiction. They are Chile, Ecuador, Estonia, Jordan, Latvia, Mexico, Norway, Paraguay, Uruguay, Russia, Slovenia, Sweden, and Venezuela.