Retrieved December 17, 2014 V&A # 2710 IP determines the parallel importation of a medicinal product authorized EMCONCOR COR antihipertensor 2.5 mg 28 tabl. from Spain with 63046 authorization number C.N. 869735.9, which, for the reasons expressed above, must be marketed under the name Congescor and with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this Determination: importer: GMM Farma S.r.l. 8105/10-80035 Nola Lots 8, CIS Nola Island;
Pack size: 28 tablets in PVC/AL CONGESCOR from 2.5 mg AIC Code: 043654019 (10) 19N6W3 (based on 32) dosage form: tablets each tablet contains: active ingredient: Bisoprolol hemifumarate 2.5 mg inactive ingredients: anhydrous calcium hydrogen phosphate, corn starch, colloidal silicon dioxide, Crospovidone, microcrystalline cellulose, magnesium stearate, hypromellose, Macrogol 400, 100 Dimethicone, titanium dioxide (E 171).
Medical indications: treatment of chronic heart failure with reduced left ventricular systolic function, stable, in addition to ACE inhibitors and diuretics and possibly cardiac glycosides.
Secondary repackaging authorized secondary packaging at Pharma Partners S.r.l. Via Locchi 112-50141 Florence; S.C.F. S.n.c. By Gano Roberto and Claudio Pelizzola Mirko Via F. Barbarossa, 7 26824 Cavenago d'Adda (LO); De Health S.r.l. Via Antonio Biasini, 26-26015 Soresina (CR); FIEGE Logistics Italy S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI);
Classification for the purposes of new listings ' container: CONGESCOR 28 tablets in PVC/AL from 2.5 mg Code AIC: 043654019; New listings ' class: C (nn) the package described above is placed in "special section" of the classroom under art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn), pending the submission by the holder of the AIP a possible application for different classification Classification for the purposes of delivery set: CONGESCOR 28 tablets in PVC/AL from 2.5 mg AIC Code : 043654019; RR-prescription medicines;
Date of determination: from the day following its publication in the official journal of the Italian Republic.