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Novartis Successfully Completes European Mutual Recognition Procedure for Myfortic(R) -- its New Immunosuppressant
BASEL, Switzerland, Feb. 10, 2004 (PRIMEZONE) -- Novartis Pharma AG (NYSE:NVS) announced today that its application for the new enteric-coated immunosuppressant, Myfortic (mycophenolate sodium) successfully completed the European Mutual Recognition Procedure (MRP) in 17 countries. Myfortic is a life-long adjunctive therapy in combination with ciclosporin, such as Neoral(r) (ciclosporin microemulsion), and corticosteroids for the prevention of acute rejection of kidney allografts (transplants) in adult patients. All countries involved in the MRP are expected to issue a marketing authorization in the coming months. "This is extremely good news for transplant patients and healthcare professionals as Myfortic provides a valuable new immunosuppressive treatment option that combines excellent efficacy and good tolerability," said Professor Georges Mourad, Director, Department of Nephrology and Transplantation, Hospital Lapeyronie, France. "Gastrointestinal side effects frequently observed under current mycophenolate mofetil or MPA therapy are a cause of discomfort for patients and may result in dose reduction or treatment discontinuation. This can pose difficult treatment decisions for transplant physicians, as these dose reductions or interruptions are associated with decreased graft survival."