Renewal Of The Marketing Authorisation For The Medicinal Product For Human Use, National Secondoprocedura, Ibo», «Oxygen Fill Review Boards.

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio, secondoprocedura nazionale, del medicinale per uso umano «Ossigeno IBO», conconseguente modifica stampati.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-02&atto.codiceRedazionale=15A00590&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the 382/2014 November 19, 2014 The PV no authorisation for the medicinal product: OXYGEN IBO.
Packaging: A.I.C. # 039103 015 «gas cryogenic medicine» Cryo-container fixed from 1500 litres;
A.I.C. # 039103 027 «gas cryogenic medicine» Cryo-container fixed from 5000 litres;
A.I.C. # 039103 039 «gas cryogenic medicine» cryogenic container from 31 litres;
A.I.C. # 039103 041 «gas cryogenic medicine» cryogenic container hallway 37 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 054 «medicinal» steel with vr regulator from 0.5 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 066 «medicinal» steel with vr regulator from 2 liters;
A.I.C. # 200 bar compressed gas cylinder 039103 078 «medicinal» steel with vr regulator from 3 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 080 «medicinal» steel with vr regulator from 5 litres;
A.I.C. # 039103 193 200 bar compressed gas cylinder «medicinal» steel with valve gives you 5 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 092 «medicinal» steel with pressure reducing valve vr to 7 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 179 «medicinal» steel with valve gives you 7 litres 200 bar # 039103 104 A.I.C. «gas valve steel cylinder compressed» medicine gives you 10 litres;
A.I.C. # 039103 116 200 bar compressed gas cylinder «medicinal» steel with vr regulator from 14 litres;
A.I.C. # 039103 128 ' 200 bar compressed gas steel cylinder with valve ' medicine there from 14 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 181 «medicinal» steel with vr regulator from 27 litres;
A.I.C. # 200 bar compressed gas cylinder 039103 130 «medicinal» steel with valve gives you 27 litres 200 bar gas # 039103 142 «A.I.C. compressed steel cylinder with valve ' medicine gives 40 liters;
A.I.C. # 039103 155 200 bar compressed gas cylinder «medicinal» steel with valve gives you 50 litres;
A.I.C. # 039103 167 200 bar compressed gas cylinders ' medicinal package with steel cylinders 16» from valve there 40 litres.
A.I.C. holder: IBO-Brescian Oxygen Industry S.r.l.
How to: national, ending on January 7, 2015 is renewed, with unlimited validity, the marketing authorisation subject to amendment of the summary of product characteristics, package leaflet and labelling and on condition that, on the date of entry into force of this determination, the requirements of quality, safety and efficacy are still present.
Changes must be made immediately to the summary of the product characteristics as per the package leaflet and labelling no later than six months after its publication in the Official Gazette of the Italian Republic of this determination.
In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s 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 Decree.
Both lots already products as of the date of publication in the official journal of the Italian Republic of this determination that the batches produced during the period referred to in art. 2, paragraph 2, of the aforementioned determination, which did not indicate the changes authorized, can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The A.I.C. holder makes accessible to pharmacist leaflet updated within the same timeframe.
This determination takes effect from the day following that of its publication in the official journal of the Italian Republic and will be notified to the company holder of the marketing authorisation of the medicinal product.