Intercell: Licensure application for Japanese Encephalitis vaccine submitted to Therapeutic Goods Administration in Australia
Intercell AG announced the submission of application to register Intercells investigational Japanese encephalitis vaccine in Australia to the Therapeutic Goods Administration (TGA). The submission process was executed by Intercells partner CSL Biotherapies Pty Ltd.
This TGA submission has been based on the Market Authorization Application (MAA) with the European Medicines Agency (EMEA) and the Biological License Application (BLA) with the US Food and Drug Administration (FDA), submitted in December 2007.
In Australia Intercell cooperates with CSL Biotherapies Pty Ltd., who has the exclusive right for marketing and distribution of Intercells novel cell culture based Japanese Encephalitis vaccine in Australia, New Zealand, Papua New Guinea and Pacific Islands. The initial target for use of Intercells vaccine will be adult civilian travellers and military personnel who visit or are deployed to affected countries, including India, China, and Southeast / Southwest Asia, and consequently also people living in endemic regions.
The production of the vaccine for the Australian market will be performed at Intercells vaccine manufacturing facility in Livingston, Scotland.
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