Authorisation For The Medicinal Product For Usoumano «Protoxan».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-09&atto.codiceRedazionale=15A00804&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved 4 January 14, 2015 2015 V&A determines the #/Description of the medicinal product and assigning AIC.
It is authorised for placing on the market of the medicinal product: PROTOXAN in form and packaging: «+50% 50% gas medicine» aluminium valve 2 cylinder lt PRV, 50% +50% gas ' medicinal product ' 2 cylinder lt aluminum with integrated regulator, in addition to the packaging already authorised, under the conditions and with the specifications mentioned below: Mah: Rivoira Pharma S.r.l., Via Durini , 7 20122 Milan, Italy, social security-08418370964 50% +50% gas Pack: "medicine» aluminium cylinder valve PRV 2 lt-AIC # 042646101 (10) 18PGLP (based on 32) dosage form: medicinal compressed gas composition: active ingredient: nitrous oxide (N2O medicine) 50% v/v and oxygen (O2 medicine) 50% v/v-170 bar (15° C);
Packaging: "50% +50% medicinal gas" bottle 2 lt aluminum with integrated regulator-AIC # 042646113 (10) 18PGM1 (based on 32) dosage form: medicinal compressed gas composition: active ingredient: nitrous oxide (N2O medicine) 50% v/v and oxygen (O2 medicine) 50% v/v-170 bar (15° C).
New listings for the purposes of classification is packaging: "50% +50% medicinal gas" bottle 2 lt with aluminum valve PRV-AIC # 042646101 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).
Packaging: "50% +50% medicinal gas" bottle 2 lt aluminum with integrated regulator-AIC # 042646113 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: "50% +50% medicinal gas cylinder valve aluminum 2 lt" PRV-AIC # 042646101 1:56 1:56: medicinal products subject to medical prescription, that can be used exclusively by specialists identified in accordance with the provisions of regions and autonomous provinces 50% +50% packaging: "medicinal" gas canister from 2 lt aluminum with integrated regulator-AIC # 042646113 1:56 1:56 : medicinal products subject to medical prescription, that can be used exclusively by specialists identified in accordance with the provisions of regions and autonomous provinces Printed cartons of material should be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt to the determination, under this extract.
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.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14, paragraph 2 of Legislative Decree No 219 April 24, 2006 and s, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 107-quater, para. 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, to decompress, in Gazzetta Ufficiale della Repubblica italiana.