Authorisation For The Medicinal Product For Oxygen Usoumano «Sol».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01903&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 23, 2015 V&A # 337/2015 of description determines medicine and attribution MA is authorized the placing on the market of the medicinal product: OXYGEN "SOL", also in shapes and packaging: "300 BAR compressed gas steel cylinder with reducing valve" medicine complemented by 3 litres;
"300 BAR compressed gas medicine" steel cylinder with integrated regulator from 5 litres;
"300 BAR compressed gas medicine" steel cylinder with integrated regulator 10 litres;
"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 3 litres;
"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 5 litres;
"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator to 10 litres, under the conditions and with the specifications below.
MAh: SOL S.p.A., with registered office and tax domicile in Via Borgazzi, 27, 20052-Monza (MB) Italy, tax code 04127270157.
Packaging: "300 BAR compressed gas steel cylinder with reducing valve" medicine integrated with 3 liters-AIC # 039132396 (10) 15B77D (based on 32) "300 BAR compressed gas steel cylinder with reducing valve" medicine complemented with 5 liters-AIC # 039132408 (10) 15B77S (based on 32) "300 BAR compressed gas steel cylinder with reducing valve" medicine complemented by 10 litres-AIC # 039132410 (10) 15B77U (based on 32) "300 BAR gas medicine aluminium cylinder with integrated regulator "compressed from 3 liters-AIC # 039132422 (10) 15B786 (based on 32)" medicinal gas cylinder 300 BAR compressed "in aluminum with integrated regulator from 5 litres-AIC # 039132434 (10) 15B78L (based on 32)" medicinal gas cylinder 300 BAR compressed "in aluminum with integrated regulator 10 litres-AIC # 039132446 (10) 15B78Y (based on 32) pharmaceutical form : Inhalation Gas composition: active ingredient: Oxygen 100% healthy product validity: 5 years from date of manufacture Manufacturer of the active substance: Sol S.p.A., Viale unification of Italy, 49--57025 Piombino (LI); Sol S.p.A., Via Firmio 2-84100-leontius, Salerno; Sol S.p.A., Viale del Lavoro, 12-37036-San Martino Buon Albergo (VR); Sol S.p.A., Via Taliercio, 14-46100-Mantova; Air Liquide Italy Production S.r.l., S.S. 195, km 17.200-09018-Sarroch (CA); Air Liquide Italy Production S.r.l., Via industry-28-37014 Castelnuovo del Garda (VR); Air Liquide Italy Production S.r.l., Via Dante s.n.c-20090-Pioltello (MI); Chemgas S.r.l., Via e. Fermi-72100-Brindisi; Linde Gas Italy S.r.l.-Via Turati, 18/a--40010 Sala Bolognese (BO); Linde Gas Italy S.r.l.-Via di Servola, 1-34100 Trieste; Sapio Produzione Idrogeno Ossigeno S.r.l.-Via Senator Simontetta, 27-20040-Caponago (MI); Sapio Produzione Idrogeno Ossigeno S.r.l., Via Malcontenta, 49 (localita ' Porto Marghera)-30175 Venezia; Rivoira Operations S.r.l., Via Glair,-30-11029 Verres (AO); Rivoira Operations S.r.l., Via Baiona, 107/111-48100 Ravenna; Societa ' Italiana Acetylene & Derived "S.I.A.D." S.p.a., S.S. del Brembo, 1, 24040-Osio Sopra (BG); SICO Societa ' Italiana S.p.A., Via Marconato s.n.c Oxygen-Carbide-20031 Cesano Maderno (MI); Lonza AG, Lonzastrasse Visp-Switzerland; SPG-SOL Plin Gorenjska, proizvodnja in prodaia tehnicnih plinov, d.o.o Cesta 1, Slovenia, 42-Maja.
Manufacturer of the finished product: SOL S.p.A. factory site in Cremona, Via Acquaviva 4 (all phases).
Medical indications: treatment of acute and chronic respiratory failure;
treatment in anesthesia in intensive care in a hyperbaric chamber.
Classification for the purposes of new listings package: AIC # 039132396-"300 BAR compressed gas medicine" steel cylinder with integrated regulator from 3 litres of Class new listings ': 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 # 039132408-"300 BAR compressed gas medicine" steel cylinder with integrated regulator from 5 liters 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 # 039132410-"300 BAR compressed gas medicine" steel cylinder with integrated regulator to 10 litres of Class new listings ': 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 # 039132422-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 3 litres of Class new listings ': 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 # 039132434-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 5 liters 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 # 039132446-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator to 10 litres of Class new listings ': 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 # 039132396-"300 BAR compressed gas medicine" steel cylinder with integrated regulator from 3 liters-RR: medicinal product subject to medical prescription.
Package: AIC # 039132408-"300 BAR compressed gas medicine" steel cylinder with integrated regulator from 5 litres-RR: medicinal product subject to medical prescription.
Package: AIC # 039132410-"300 BAR compressed gas medicine" steel cylinder with integrated regulator 10 litres-RR: medicinal product subject to medical prescription.

Package: AIC # 039132422-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 3 liters-RR: medicinal product subject to medical prescription.
Package: AIC # 039132434-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator from 5 litres-RR: medicinal product subject to medical prescription.
Package: AIC # 039132446-"300 BAR compressed gas medicine" aluminum cylinder with integrated regulator 10 litres-RR: medicinal product subject to medical prescription.
Packaging of printed material should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
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.
Date of application of the determination on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.