Regulatory Actions

Astellas Announces the Launch of Advagraf in the UK and Germany

Published in Medical Letter on the CDC and FDA, July 8th, 2007

Astellas Pharma Inc. (headquarters: Tokyo, President and CEO: Masafumi Nogimari, "Astellas") today announced the launch of the immunosuppressant, Advagraf (generic name: tacrolimus, prolonged release capsules) in the UK and Germany by Astellas' European subsidiaries on June 18, 2007 (local time).

Astellas' European subsidiary submitted a Marketing Authorization Application (MAA) for Advagraf under the centralized procedure to the European Medicines Agency (EMEA) in January 2006. This was followed by the European Commission's approval of Advagraf on April 23, 2007. Advagraf is indicated for the "Prophylaxis of transplant rejection in adult kidney or liver allograft...

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Source: Medical Letter on the CDC and FDA (2007-07-08)

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