Parallel Import Licence For Medicinal Usoumano «Triatec».

Original Language Title: Autorizzazione all'importazione parallela del medicinale per usoumano «Triatec».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-15&atto.codiceRedazionale=15A02711&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 20, 2015 V&A # 548 IP determines the parallel importation of a medicinal product authorized DELIX 2.5 mg tabletten 100 tabletten PVC/Al-Blisterpackung from Germany with 45696.01.00 authorization number, which for the reasons expressed above, must be marketed under the name Triatec and with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination : importer: PRICETAG SPA with registered office in Vasil Levski St. 103-1000 Sofia;
Package: TRIATEC "2.5 mg tablet" AIC Code 28 scored tablets: 043315035 (10) 199VUV (based on 32) composition: each tablet contains: active ingredient ramipril 2.5 mg: divisible.
Excipients: hypromellose, pregelatinised maize starch, microcrystalline cellulose, sodium Stearyl fumarate, yellow iron oxide and 172.
Indications treatment of hypertension.
Cardiovascular prevention: reduction of cardiovascular mortality in patients with morbilita ' and: • cardiovascular diseases overt aterotrombotiche (previous coronary artery disease or stroke, or peripheral vascular disease) or • diabetes with at least one cardiovascular risk factor (see section 5.1) treatment of kidney diseases: • incipient Glomerular nephropathy diabetic, defined by the presence of microalbuminuria • Glomerular nephropathy overt diabetic, defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1) • Glomerular nephropathy diabetic macroproteinuria ≥ 3 g/not full-blown defined by day (see section 5.1). Treatment of symptomatic heart failure.
• Secondary prevention after acute myocardial infarction: reduction of mortality after the acute phase of myocardial infarction in patients with clinical signs of heart failure when started after 48 hours after onset of acute myocardial infarction secondary packaging and secondary packaging are allowed at le officine FIEGE LOGISTICS ITALIA S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI); S.C.F. S.n. c. By Gano Roberto and Claudio Via f. Barbarossa, 7 Mirko Pelizzola-26824 CAVENAGO d'Adda-LO; FALORNI s.r.l. Via Provinciale Lucchese 51-loc. Masotti 51030 Serravalle Pistoiese (PT); PriceTag EAD, Business Center Serdika, 2E Ivan Geshov Blvd.-1000 Sofia;
Classification for the purposes of new listings ' box: TRIATEC "2.5 mg tablet" AIC Code 28 scored tablets: 043315035; New listings ' class: C (nn) the package described above is placed in "special section" of the class referred to in 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: TRIATEC "2.5 mg tablet" AIC Code 28 scored tablets: 043315035; RR-medicinal product subject to medical prescription;
Date of determination: from the day following its publication in the official journal of the Italian Republic.