Refusal Actions by FDA as Recorded in OASIS for Greece

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Bristol Myers Squibb Aeve
    N. Erithraia , GR                              NOL-DO  112-1358403-3/1/1
    56CCY65   862018037385 PROCEF 500MG
                        01-JUL-2008                        UNAPPROVED

    Vianex Ae L
    Trithraia , GR                                 NOL-DO  112-3476153-7/2/1
    62ODB28   865352052296/RENITEC
                        21-JUL-2008                        UNAPPROVED