Teva's generic CellCept gets CHMP OK
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Israeli generic giant Teva's Myfenax (mycophenolate mofetil), in 250mg hard capsules and 5,000mg film-coated tablets intended for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants in combination with ciclosporin and corticosteroids.
The agent, a selective immunosuppressant, is a generic of Swiss drug major Roche's CellCept which has been authorized in the European Union since 1996. Studies have demonstrated the satisfactory quality of Myfenax, and its bioequivalence with CellCept.
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