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=15A02713&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 20, 2015 V&A # 547 IP determines the parallel importation of a medicinal product authorized Delix protect 10 mg Tabletten 100 tabletten PVC/Al-Blisterpackung from Germany with 50295.00.00 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 "10 mg tablet" 28 scored tablets.
AIC code: 043315047 (10) 199VV7 (based on 32) dosage form: scored tablets.
Composition: each tablet contains: active ingredient: ramipril 10 mg divisible.
Excipients: hypromellose, pregelatinised maize starch, microcrystalline cellulose, sodium Stearyl fumarate.
Indications treatment of hypertension.
Cardiovascular prevention: reduction of cardiovascular mortality in patients with morbilita ' e: cardiovascular disease 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 incipient Diabetic Nephropathy renal Glomerular:, defined by the presence of overt diabetic microalbuminuria, defined by macroproteinuria Glomerular nephropathy 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 paragraph 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 Italy 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 "10 mg tablet" AIC Code 28 scored tablets: 043315047; 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 "10 mg tablet" AIC Code 28 scored tablets: 043315047; RR-prescription medicines.
Date of application of the determination on the day following its publication in the official journal of the Italian Republic.