Refusal Actions by FDA as Recorded in OASIS for Switzerland

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Novartis Pharma Stein AG Stein , CH CH-433 NYK-DO 506-0817461-6/6/1 66VIY99 RAD001 TABS 5MG 10-JUL-2008 UNAPPROVED Ucb Farchim Sa Z.I.De Planchy Bulle , CH 1630 NYK-DO 336-8569213-2/1/1 61XDA99 XYZAL (LEVOCETIRIZINE) TABS 11-JUL-2008 UNAPPROVED Chemo S.A. Lugano Branch Lugano , CH FLA-DO M21-0737796-4/1/1 61FAB56 CLARITHROMICIN FOR EXPORT ONLY, PLEASE REFUSE MERCHANDISE 14-JUL-2008 UNAPPROVED Ecosol Ag Cham , CH 6330 NOL-DO 112-3716516-5/1/1 62CDA65 847067944313 LISINOPRIL 5MG 25-JUL-2008 UNAPPROVED Inpharzam Blonayblonay , CH CIN-DO UPS-1676643-6/1/3 66VCA99 FLUIMUCILA/NO RX/NO ID/PER USE 30-JUL-2008 UNAPPROVED