Retrieved December 30, 2014 V&A # 2743 IP determines the parallel importation of a medicinal product authorized SORTIS 20 mg 100 tablet from Czech Republic with potahovane ' tablety authorization number 31/234/99-C, which should be placed on the market 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;
Packaging: 20 30 20 mg tablets, SORTIS «» AIC Code: 043648017 (10) 18N10K (based on 32) dosage form: tablets composition: a coated tablet contains: active ingredient: atorvastatin 20 mg (as atorvastatin calcium trihydrate).
Tablet core: calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, croscarmellose sodium, polysorbate 80 (E433), hyprolose (E463), magnesium stearate (E572);
Film coating: hypromellose (E464), Macrogol 8000, titanium dioxide (E171), talc (E553b), Simethicone, stearates, emulsifiers, gelling agents (methyl cellulose, xanthan gum), benzoic acid, sorbic Acid.
Medical indications: Hypercholesterolemia SORTIS is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years and above is equal with primary hypercholesterolaemia including Familial Hypercholesterolemia (heterozygous variant) or mixed hyperlipidaemia (corresponding to types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
SORTIS is also indicated to reduce total cholesterol and LDL cholesterol in adult subjects with homozygous Familial Hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL Apheresis) or if such treatments are not available.
Prevention of cardiovascular disease prevention of cardiovascular events in adults at high risk for a first cardiovascular event in addition to correction of other risk factors.
Secondary secondary authorised repackaging repackaging 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: 20 30 20 mg tablets, SORTIS «» AIC Code: 043648017; 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: 20 30 20 mg tablets, SORTIS «» AIC Code: 043648017; RR-prescription medicines;
Date of determination: from the day following its publication in the official journal of the Italian Republic.