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Sanofi-Aventis wins Australian approval for influenza vaccine

Also wins positive recommendation by the Australian Drug Evaluation Committee

Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, has received marketing authorization from the Australian Therapeutic Goods Administration for Emerflu, the company’s pandemic influenza vaccine for human use.

Emerflu vaccine is now approved for the prevention of pandemic influenza in Australia upon official declaration of a pandemic. Emerflu vaccine is intended to be manufactured and distributed with the identified pandemic strain and used in Australia in accordance with official Australian government guidance, the company said.

The Australian approval of Emerflu vaccine granted follows the positive recommendation by the Australian Drug Evaluation Committee, based on a review of results from clinical trials, which began in late 2004 on H5N1 alum-adjuvanted inactivated influenza vaccine candidates.

Wayne Pisano, president and chief executive officer of Sanofi Pasteur, said: The Australian Therapeutic Goods Administration’s recommendation of Emerflu vaccine marks a new milestone in pandemic preparedness. As the world’s leading influenza vaccine manufacturer, Sanofi Pasteur aims at contributing to the efforts of World Health Organization, Australia and other countries around the world to safeguard human health in the event of an influenza pandemic.

Sanofi Pasteur offers a broad range of vaccines providing protection against 20 bacterial and viral diseases.