Regulatory Approvals

The table below identifies the key regulatory approvals. Additional approvals have been received for individual markets.

For further information on specific approvals, please contact your local distributor.

Country	Regulatory Body		Approval
United States of America		US Food and Drug Administration	February 2011
Canada		Health Canada	September 2008
		Sonex-HL – Drug Identification Number (DIN)	March 2012
Europe		TUVRheinland	April 2008
Australia		Australian Therapeutics Goods Administration	February 2009
New Zealand		Medsafe: New Zealand Medicines and Medical Devices Authority	November 2008