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Wednesday, September 14, 2005
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First fish vaccine ever to be approved through the EU's Mutual Recognition procedure

EU – Schering Plough Animal Health's dedicated Aquaculture business unit has recently received approval of their vaccine for the protection of Rainbow Trout from Enteric Red Mouth Disease (Yersiniosis) through the European Union's mutual recognition procedure (MRP).

First fish vaccine ever to be approved through the EU's Mutual Recognition procedure - EU – Schering Plough Animal Health's dedicated Aquaculture business unit has recently received approval of their vaccine for the protection of Rainbow Trout from Enteric Red Mouth Disease (Yersiniosis) through the European Union's mutual recognition procedure (MRP). Schering-Plough Animal Health

The AQUAVAC*ERM vaccine is a historical first for a number of reasons. It was the first experimental fish vaccine developed in the late 1970's. It was also the first ever licensed fish vaccine and the first fish vaccine to be licensed in Europe. It is also the first ever fish vaccine to be approved through the Mutual Recognition Procedure in the European Union.

AQUAVAC*ERM was already available in the UK, France, Ireland, Denmark, Italy and Germany but will now also become available in Austria, Czech Republic, Greece , Spain, Norway, Poland, Portugal, Slovakia and Slovenia.

Richard Braley of SPAH's regulatory department says of the new approval. "The successful completion of the MRP allows SPAH to request marketing authorizations across member states of Europe for AQUAVAC*ERM, based upon the marketing authorization held in the reference state which for this vaccine is the UK. The success of this process reflects the work put in by the whole of SPAH's Aquaculture team over many years for this product, and the team will be making every effort to approve further vaccines through the MRP."

The Aquaculture Business Unit of the Schering-Plough Animal Health Corporation is a world leader in the discovery, development and marketing of pharmaceutical and biological products for the treatment and control of aquatic animal diseases. Through research and technical expertise, Schering-Plough Aquaculture enables fish farmers to improve production while helping ensure the sustainability of fish farming throughout the world.

For more information, please visit www.spaquaculture.com.

Source: Schering-Plough Animal Health - 14th September 2005



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