This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.