Authorisation For The Medicinal Product For Usoumano «Copaxone».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01904&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 23, 2015 2015 # 348/V&A of determines Description and attribution MA is authorized the placing on the market of the medicinal product: "'' COPAXONE ''", in both shape and packaging: "40 mg/ml solution for injection in pre-filled syringes from 1 ml with 12" needle;
"40 mg/ml solution for injection in pre-filled" 3 syringes from 1 ml with needle;
"40 mg/ml solution for injection in pre-filled" 3 × 12 syringes from 1 ml with needle;
under the conditions and with the specifications below.
MAh: Teva Pharmaceuticals Limited, having its registered office and tax domicile in Castleford, West Yorkshire, WF10, Ridings Point, Whistler Drive 5HX, United Kingdom (uk) packaging: "40 mg/ml solution for injection in pre-filled syringes from 1 ml 12" with needle-AIC # 035418060 (10) 11SVYD (based on 32) "40 mg/ml solution for injection in pre-filled syringes from 1 ml 3" with needle-AIC # 035418072 (10) 11SVYS (based on 32) "40 mg/ml solution for injection in pre-filled syringes from 1 ml 3 × 12 "with needle-AIC # 035418084 (10) 11SVZ4 (based on 32) dosage form: complete appliance solution for injection validity: 2 years from date of manufacture the active substance manufacturer: Plantex LTD factory site in Hakadar Street, Old Industrial Center Kiryat Eliezer, P.O. Box 160 Netanya, 42101-Israel; Assia Chemicalindustries LTD (Teva Tech Manufacturing Site) plant site in Neot Emek Sara, P.O. Box 2049, Beer Sheva 84874-Israel; Teva Pharmaceuticals Industries LTD factory site in 18 Eli Hurvitz Street, Industrial Zone 4,410,202 Kfar Saba-P.O. Box 353-Israel.
Manufacturer of the finished product: Teva Pharmaceuticals Industries LTD factory site in 18 Eli Hurvitz Street, Industrial Zone 44102 Kfar Saba-P.O. Box 353-Israel (production, control, primary and secondary packaging); Norton Healthcare Limited T/A Ivax Pharmaceuticals UK (Teva Runcorn) plant site in Aston Lane North, Whitehouse Lane Industrial Estate, Preston Brook, Runcorn, Cheshire WA7 3FA-United Kingdom (production, control, primary and secondary packaging); Pharmachemie B.V. Haarlem, 5, Swensweg site City settlement 2031 GA-Netherlands (control); Plantex LTD factory site in Hakadar Street, Old Industrial Center 160 Netanya, Kiryat Eliezer, P.O. Box 42101-Israel (control); Teva Pharmaceutical Works Private Limited plant site in Pallagi Street 13, City Debrecen, Hungary-4042 (control); Teva Pharmaceutical Works Private Limited plant in Godollo, Hungary Tancsics Mihaly Street 2100-82 (supervision); ABIC Ltd./Teva Pharmaceutical Industries LTD. factory site in 19 Giborey Israel Street P.O. Box 8077 Netanya-Israel Kiryat Sapir 4,250,419 New Industrial Zones (control); Teva Pharmaceutical Industries LTD factory site in 2 Hamarpe Street P.O. Box 11,429,777,402 Jerusalem-Israel (control); Merckle GMBH plant in Graf-Arco-Str 389,079 Ulm-Germany (outer packaging); Transpharm Logistic GMBH plant in Nicolaus-Otto-Straße 1,689,079 Ulm-Germany (outer packaging); Teva Pharmaceutical Europe BV plant site in Swensweg 5, City Haarlem, Netherlands 2031 GA-(release).
Composition: a syringe to 1 ml solution for injection contains: active ingredient: glatiramer acetate * 40 mg (equivalent to 36 mg of glatiramer) excipients: mannitol; water for injections; * glatiramer acetate is synthetic polypeptides acetate salt containing four natural amino acids: L-glutamic acid, L-alanine, L tyrosine and L-lysine, in areas of mole fraction -0.462, respectively -0.100 and -0.153, 0.129 0.392 0.086 0.300 -0.374. The average molecular weight of glatiramer acetate is between 5,000-9,000 Daltons.
Medical indications: Copaxone is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see section 5.1 of the summary of product characteristics for important information on population in which effectiveness has been established).
COPAXONE is not indicated in patients with primary or secondary progressive Ms.
Classification for the purposes of new listings package: AIC # 035418060-"40 mg/ml solution for injection in pre-filled" 12 syringes from 1 ml with needle 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 # 035418072-"40 mg/ml solution for injection in pre-filled" 3 syringes from 1 ml with needle 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 # 035418084-"40 mg/ml solution for injection in pre-filled" 3 × 12 syringes from 1 ml with needle 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 # 035418060-"40 mg/ml solution for injection in pre-filled syringes from 1 ml 12" with needle-RR: medicinal product subject to medical prescription packaging: AIC # 035418072-"40 mg/ml solution for injection in pre-filled syringes 1 ml to 3" with needle-RR: medicinal product subject to medical prescription packaging: AIC # 035418084-"40 mg/ml solution for injection in pre-filled syringes from 1 ml 3 × 12" with needle-RNR : medicinal product subject to medical prescription to be renewed from time to time Printed on the packaging 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) under art. 107-quater, para. 7) of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of application of the determination on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.