Retrieved determines the IP V&A December 30, 2014 # 2752 is authorized the parallel importation of medicine ZOCOR 20 mg. Tablet film. 28 tabl. from the Czech Republic with 31/155/authorization number 92-B/C which for the reasons expressed in the introduction should be placed on the market under the name Sinvacor 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;
Package: SINVACOR «20 mg film-coated tablets» 28 tablets AIC Code: 043655012 (10) 19N7V4 (based on 32) dosage form: tablets each tablet contains: active ingredient: 20 mg of simvastatin.
Excipients: lactose monohydrate, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, red iron oxide, yellow iron oxide;
Medical indications: Hypercholesterolemia treatment of primary hypercholesterolemia or Mixed Dyslipidemia, as diet supplement, when response to diet and other non-pharmacological treatments (eg. exercise, weight reduction) is inadequate.
Treatment of homozygous Familial Hypercholesterolemia as diet supplement and other lipid-lowering treatments (eg. LDL Apheresis) or if such treatments are not appropriate.
Cardiovascular mortality Reduction and prevention morbilita cardiovascular atherosclerotic disease in patients ' cardiovascular disease or diabetes mellitus, with normal cholesterol levels or increased, as an adjunct for the correction of other risk factors and other therapies cardioprotective.
Secondary packaging is authorized repackaging secondary at officine Pharma Partners S.r.l. Via Locchi 112-50141 Florence; 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); S.C.F. S.n.c di Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda;
Classification for the purposes of new listings ' box: SINVACOR «20 mg film-coated tablets» 28 tablets AIC Code: 043655012; 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 SINVACOR «20 mg film-coated tablets» 28 tablets AIC Code: 043655012; RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.