Authorisation For The Medicinal Product For Usoumano «Octanate».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10118&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the 2681/2014 December 16, 2014 n V & is authorised the placing on the market of the medicinal product: OCTANATE, shapes and packaging: «100 IU/ml powder and solvent for solution for injection 500 IU + 1 ' 1 vial powder solvent vial from 5 ml + set for injection; «200 IU/ml powder and solvent for injectable solution» 1 vial of powder 1000 IU + 1 vial of solvent from 5 ml + set for injection; under the conditions and with the specifications below.
A.I.C. holder: Octapharma Italy S.p.a., with registered office and tax domicile in Pisa, via Cisanello # 145-cap 56100, Italy, tax code # 01887000501.
Package: «100 IU/ml powder and solvent for solution for injection 500 IU + 1 ' 1 vial powder solvent vial from 5 ml + set for injection, A.I.C. n. 040112056 (in base 10), 1683XS (32).
Pharmaceutical form: powder and solvent for solution for injection.
Complete appliance validity: two years from the date of manufacture.
Octapharma Pharmazeutika Produktionsges. Manufacturer of the active substance: M.b.h., Oberlaaer Strasse 235-A-site settlement 1100 Vienna-Austria; Octapharma S.A.S., settlement site at 72 rue du Marechal Foch 67380-Lingolsheim-France; Octapharma AB, S-112 75 Stockholm-Sweden site establishment.
Octapharma Pharmazeutika Produktionsges. Manufacturer of the finished product: M.b.h., Oberlaaer Strasse 235-A-site settlement 1100 Vienna-Austria (production, primary and secondary packaging, control, release); Octapharma S.A.S., settlement site at 72 rue du Marechal Foch 67380-Lingolsheim-France (production, primary and secondary packaging, control, release); Octapharma AB, S-112 75 Stockholm-Sweden site establishment (production, primary and secondary packaging, control, release); Bbraun Medical S.A., factory site in Ronda de los Oliveras, parcela 11, Poligono Industrial Los Oliveras-23009 Jaen-Spain (production of solvent water for injection); Solupharm GmbH, Pharmaceutical Products, factory site in Industriestr. 3-34212 Melsungen-Germany (production of solvent water for injection); OCTAPHARMA GMBH factory site in eight 3-06847 Dessau-Germany-Reuter-Strasse (outer packaging).
Composition: 5 ml of reconstituted solution for injection contain: active ingredient: 500 human coagulation factor VIII IU;
excipients: powder: sodium citrate; sodium chloride; calcium chloride; glycine;
solvent: water for injection.
Package: «200 UI/ml powder and solvent for injectable solution» 1 vial of powder 1000 IU + 1 vial of solvent from 5 ml + set for injection, A.I.C. n. 040112068 (in base 10), 1683Y4 (32).
Pharmaceutical form: powder and solvent for solution for injection.
Complete appliance validity: two years from the date of manufacture.
Octapharma Pharmazeutika Produktionsges. Manufacturer of the active substance: M.b.h., Oberlaaer Strasse 235-A-site settlement 1100 Vienna-Austria; Octapharma S.A.S., settlement site at 72 rue du Marechal Foch 67380-Lingolsheim-France; Octapharma AB, S-112 75 Stockholm-Sweden site establishment.
Octapharma Pharmazeutika Produktionsges. Manufacturer of the finished product: M.b.h., Oberlaaer Strasse 235-A-site settlement 1100 Vienna-Austria (production, primary and secondary packaging, control, release); Octapharma S.A.S., settlement site at 72 rue du Marechal Foch 67380-Lingolsheim-France (production, primary and secondary packaging, control, release); Octapharma AB, S-112 75 Stockholm-Sweden site establishment (production, primary and secondary packaging, control, release); Bbraun Medical S.A., factory site in Ronda de los Oliveras, parcela 11, Poligono Industrial Los Oliveras-23009 Jaen-Spain (production of solvent water for injection); Solupharm GmbH, Pharmaceutical Products, factory site in Industriestr. 3-34212 Melsungen-Germany (production of solvent water for injection); Octapharma GmbH factory site in eight 3-06847 Dessau-Germany-Reuter-Strasse (outer packaging).
Composition: 5 ml of reconstituted solution for injection contain: active ingredient: human coagulation factor VIII 1000 IU;
excipients: powder: sodium citrate; sodium chloride; calcium chloride; glycine;
solvent: water for injection.
Medical indications: treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
This preparation contains no von Willebrand factor in pharmacologically effective doses and is not indicated for von Willebrand's disease.
Classification for the purposes of new listings ' packaging: A.I.C. # 040112056-«100 IU/ml powder and solvent for solution for injection 500 IU + 1 ' 1 vial powder solvent vial from 5 ml + set for injection, new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537, and subsequent amendments, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn) ';
A.I.C. # 040112068-200 IU/ml powder and solvent for solution for injection» 1 vial of powder 1000 IU + 1 vial of solvent from 5 ml + set for injection, new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn) ".
Classification for the purpose of packaging: A.I.C. # 040112056-«100 IU/ml powder and solvent for solution for injection 500 IU + 1 ' 1 vial powder solvent vial from 5 ml + set for injection-RR: medicinal product subject to medical prescription;
A.I.C. # 040112068-200 IU/ml powder and solvent for solution for injection» 1 vial of powder 1000 IU + 1 vial of solvent from 5 ml + set for injection-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 Legislative Decree No 219, April 24, 2006 and subsequent amendments and supplements the leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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) under art. 107-c, paragraph 7) of Directive 2010/84/EC 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.