Authorisation For The Medicinal Product For Usoumano «Triatec Hct».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Triatec Hct».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01332&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 14, 2015 V&A # 48/2015 determines the description of medicine and assigning AIC is authorised the placing on the market of the medicinal product: «TRIATEC HCT», in the forms and package sizes: 10 mg/12.5 mg tablets "» 10 tablets in PVC-Al; «10 mg/12.5 mg tablets» 14 tablets in PVC-Al; «10 mg/12.5 mg tablets» 28 tablets in PVC-Al; «10 mg/12.5 mg tablets» 30 tablets in PVC-Al; «10 mg/12.5 mg tablets» 56 tablets in PVC-Al; «10 mg/12.5 mg tablets» 60 tablets in PVC-Al; «10 mg/12.5 mg tablets» 100 tablets in PVC-Al; «10 mg/25 mg tablets» 10 tablets in PVC-Al; «10 mg/25 mg tablets» 14 tablets in PVC-Al; «10 mg/25 mg tablets» 28 tablets in PVC-Al; «10 mg/25 mg tablets» 30 tablets in PVC-Al; «10 mg/25 mg tablets» 56 tablets in PVC-Al; «10 mg/25 mg tablets» 60 tablets in PVC-Al; «10 mg/25 mg tablets» 100 tablets in PVC-Al; In addition to the packaging already authorized under the conditions and with the specifications mentioned below: Mah: Sanofi S.p.a., with registered office and tax domicile in Milano, viale Luigi Bodio, 37/B, postal code 20158, Italy, tax code 00832400154;
Packaging: "10 mg/12.5 mg tablets" 10 tablets in PVC-Al-AIC # 028531034 (10) 0V6QBU (based on 32).
Packaging: "10 mg/12.5 mg tablets" 14 tablets in PVC-Al-AIC # 028531046 (10) 0V6QC6 (based on 32).
Packaging: "10 mg/12.5 mg tablets" 28 tablets in PVC-Al-AIC # 028531059 (10) 0V6QCM (based on 32).
Packaging: "10 mg/12.5 mg tablets" 30 tablets in PVC-Al-AIC # 028531061 (10) 0V6QCP (based on 32).
Packaging: "10 mg/12.5 mg tablets" 56 tablets in PVC-Al-AIC # 028531073 (10) 0V6QD1 (based on 32).
Packaging: "10 mg/12.5 mg tablets" 60 tablets in PVC-Al-AIC # 028531085 (10) 0V6QDF (based on 32).
Packaging: "10 mg/12.5 mg tablets" 100 tablets in PVC-Al-AIC # 028531097 (10) 0V6QDT (based on 32).
Dosage form: tablets.
Complete appliance validity: 3 years from date of manufacture.
Manufacturer of the active substance: Sanofi-Aventis Deutschland Gmbh plant in Industriepark Hoechst-65926 Frankfurt am Main-Germany; Cambrex Prodrug Milano S.r.l. factory located in Via Curiel, 34 I-20067 Paullo-Milan; Teva Pharmaceutical Industries Ltd API Division plant in Abic LTD-Kyriat Sapir Industrial Zone-Netanya 42504-Israel.
Manufacturer of the finished product: Sanofi-Aventis S.p.a. factory site in Highway 17, Km 22-67019 Scoppito-L'aquila (production, primary and secondary packaging, control and release); Sanofi-Aventis Deutschland Gmbh plant in Industriepark Hoechst-65926 Frankfurt am Main-Germany (production of ramipril granules);
Composition: each tablet contains: active ingredient: ramipril 10.0 mg; hydrochlorothiazide 12.5 mg;
Excipients: hypromellose; pregelatinized corn starch; microcrystalline cellulose; red iron oxide (E172); yellow iron oxide (E172); sodium Stearyl fumarate;
Packaging: "10 mg/25 mg tablets" 10 tablets in PVC-Al-AIC # 028531109 (10) 0V6QF5 (based on 32).
Packaging: "10 mg/25 mg tablets" 14 tablets in PVC-Al-AIC # 028531111 (10) 0V6QF7 (based on 32).
Packaging: "10 mg/25 mg tablets" 28 tablets in PVC-Al-AIC # 028531123 (10) 0V6QFM (based on 32).
Packaging: "10 mg/25 mg tablets" 30 tablets in PVC-Al-AIC # 028531135 (10) 0V6QFZ (based on 32).
Packaging: "10 mg/25 mg tablets" 56 tablets in PVC-Al-AIC # 028531147 (10) 0V6QGC (based on 32).
Packaging: "10 mg/25 mg tablets" 60 tablets in PVC-Al-AIC # 028531150 (10) 0V6QGG (based on 32).
Packaging: "10 mg/25 mg tablets" 100 tablets in PVC-Al-AIC # 028531162 (10) 0V6QGU (based on 32).
Dosage form: tablets.
Complete appliance validity: 3 years from date of manufacture.
Manufacturer of the active substance: Sanofi-Aventis Deutschland Gmbh plant in Industriepark Hoechst-65926 Frankfurt am Main-Germany; Cambrex Prodrug Milano S.r.l. factory located in Via Curiel, 34 I-20067 Paullo-Milan; Teva Pharmaceutical Industries Ltd API Division plant in Abic LTD-Kyriat Sapir Industrial Zone-Netanya 42504-Israel.
Manufacturer of the finished product: Sanofi-Aventis S.p.a. factory site in Highway 17, Km 22-67019 Scoppito-L'aquila (production, primary and secondary packaging, control and release); Sanofi-Aventis Deutschland Gmbh plant in Industriepark Hoechst-65926 Frankfurt am Main-Germany (production of ramipril granules).
Composition: each tablet contains: active ingredient: ramipril 10.0 mg; hydrochlorothiazide 25.0 mg;
Excipients: hypromellose; pregelatinized corn starch; microcrystalline cellulose; red iron oxide (E172); sodium Stearyl fumarate;
Medical indications: treatment of hypertension.
This fixed dose combination is indicated in patients whose blood pressure is adequately controlled with ramipril and hydrochlorothiazide alone at the same dose.
Classification for the purposes of new listings package: AIC # 028531034-"10 mg/12.5 mg tablets" 10 tablets in PVC-Al.
New listings ' class: 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).
Package: AIC # 028531046-"10 mg/12.5 mg tablets" 14 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531059-"10 mg/12.5 mg tablets" 28 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531061-"10 mg/12.5 mg tablets" 30 tablets in PVC-Al

New listings ' class: 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).
Package: AIC # 028531073-"10 mg/12.5 mg tablets" 56 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531085-"10 mg/12.5 mg tablets" 60 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531097-"10 mg/12.5 mg tablets" 100 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531109-"10 mg/25 mg tablets" 10 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531111-"10 mg/25 mg tablets" 14 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531123-"10 mg/25 mg tablets" 28 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531135-"10 mg/25 mg tablets" 30 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531147-"10 mg/25 mg tablets" 56 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531150-"10 mg/25 mg tablets" 60 tablets in PVC-Al new listings ' class: 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).
Package: AIC # 028531162-"10 mg/25 mg tablets" 100 tablets in PVC-Al new listings ' class: 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).
Classification for the purposes of delivery set: AIC # 028531034-"10 mg/12.5 mg tablets" 10 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531046-"10 mg/12.5 mg tablets" 14 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531059-"10 mg/12.5 mg tablets" 28 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531061-"10 mg/12.5 mg tablets" 30 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531073-"10 mg/12.5 mg tablets" 56 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531085-"10 mg/12.5 mg tablets" 60 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531097-"10 mg/12.5 mg tablets" 100 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531109-"10 mg/25 mg tablets" 10 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531111-"10 mg/25 mg tablets" 14 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531123-"10 mg/25 mg tablets" 28 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531135-"10 mg/25 mg tablets" 30 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531147-"10 mg/25 mg tablets" 56 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531150-"10 mg/25 mg tablets" 60 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Package: AIC # 028531162-"10 mg/25 mg tablets" 100 tablets in PVC-Al-RR: medicinal product subject to medical prescription.
Packaging of printed material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.

In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Periodic safety update reports PSUR-The marketing authorisation holder shall provide periodic safety update reports for this product in accordance with the requirements set out in the list of dates of reference (EURD list) referred to in article 107-quater, para. 2010/84/EC Directive 7) and published on the web portal of the European Medicines Agency.
Date of determination: from the day following that of its publication in the official journal of the Italian Republic.