Review Product Marketing Authorisation For Human Use «Oralair».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Oralair».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00238&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved V&A 2594/2014 December 9, 2014 # the determines are authorized the following variation: Add Delpharm Lille website S.A. S (Zone Industrielle de Roubaix-Est Rue de 59390 Toufflers Lys-lez-Lannoy, France) for the stages of production, secondary packaging and quality control of the finished product. Optimization of process parameters for the resulting changes in the production process: using a different equipment for mixing phase of the active substance with excipients and use a different machine for the compression stage relatively to the medicine ORALAIR and authorised pack sizes the placing in Italy following the mutual recognition procedure.
Types of variation: b. II. b. 1 in) replacement or addition of a manufacturing site for part or for the whole production process of the finished product. Site of the outer packaging.
B. II. b. 2. z) quality changes finished product Making programmatic changes to the importer by method of batch release and quality control tests on the finished product several changes b. II. b. 1 c) quality changes finished product Manufacture replacement or addition of a manufacturing site for part or the entirety of the manufacturing process of the finished product. The site where they carried out all the operations b. II. b. 3 c) quality changes finished product Manufacturing Changes in the manufacturing process of the finished product, including an intermediate product used in the manufacture of the finished product. The product is a biological/immunological medicinal product and the change requires an assessment of comparability ' how to: DE/H/1930/001-002/II/020/G Mah: STALLERGENES S.A.
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 paragraph 5 of the April 14, 2014 # 371 Determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.