Eisai gets approval for Aricept in 12 EU states

Eisai has announced that its UK subsidiary, Eisai Ltd, has received notification of the completion of the Mutual Recognition Procedure (MRP) from the Medicines and Healthcare Products Regulatory Agency (MHRA) for Aricept orodispersible tablet.

The MHRA confirmed that all 12 member states involved in the procedure have mutually recognised the UK national licence approved by the MHRA earlier this year.

Aricept orodispersible tablet is designed to make administration easier for Alzheimer’s disease patients who have difficulty swallowing tablets, in order to contribute to many patients by this new formulation.

The company has already started marketing an orodispersible tablet of Aricept in Japan since July 2004. In the US, Eisai started marketing orodispersible tablets from June 2005, and received approval in May 2005 in the UK.

The 12 member states involved in the MRP are Germany, France, Italy, Austria, Belgium, Denmark, Luxembourg, Finland, Greece, Ireland, Portugal, and Sweden. All 12 member states will now issue their own national licences in due course.

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