Review Product Marketing Authorisation For Human Use «Afluria».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02057&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 23, 2015 V&A # 339/2015 of Procedure determines EU #: DE/H/1938/001/II/064.
Type II variation: b. II. b. 3b).
Are authorized the following variation: change in the manufacturing process of the finished product, including an intermediate product used in the manufacture of the finished product-substantial changes in the manufacturing process of the active substance, likely to have a significant impact on the quality, safety and efficacy of the medicinal product;
Mixing system of Final Bulk Vaccine (FBV-3.2. P. 3.5);
Minor modifications of the text referring to Monovalent Pooled Harvest (MPH) and the virion split (p. 3.2 3.3).
With respect to medicinal product: AFLURIA and authorised pack sizes the placing in Italy following the mutual recognition procedure.
A.I.C. Holder: Biocsl Gmbh.
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 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 published in the Official Journal No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.