Review Product Marketing Authorisation For Human Use «Anbinex».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01394&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 11, 2015 V&A # 247/2015 determines the authorized the following variation: b. II. d. 1. c Review specification parameters and/or limits of the finished adding a new parameter to the specification with the corresponding test method, b. II. d. 2. d change in test procedure for the finished product other changes to a test procedure , B. II. d. 1 z) change in the specification parameters and/or limits of the finished product-other variation with respect to the medicine ANBINEX, shapes and 034330035-500 # A.I.C. packs «IU powder and solvent for solution for infusion» 1 vial powder + 1 syringe 10 ml solvent + set (flac and microf), A.I.C. # 034330047-«1000 IU powder and solvent for solution for infusion» 1 vial powder + 1 syringe 20 ml solvent + set (suitable for flac and microf) :
===================================================================== |  Da |  a | +===============================+===================================+ | Finished product specification finished product specification: |: | | Test method: Test | Test method: Test for Specific endotoxins pyrogens specification: ||: endotoxin Pyrogenic |:| | (50 I.u./Kig): passes the test AT III 0.1 IU/UI | < | +-------------------------------+-----------------------------------+ | Test for determination of | | contents of citrate on | Test method for determination of the finished product || | contents of enzyme finished product citrate || |: ion chromatography | +--------------------------------+------------------------------------+ addition of specification parameter "aspect of reconstituted solution» finished product specifications: method: Visual inspection.
Specification: a transparent solution, slightly cloudy, colorless or nearly colorless.
A.I.C. Holder: Instituto Grifols S.A. with registered office and tax domicile Polygon Levante-Calle Can Guasch, 2, 08150-Parets del Valles-Barcelona (Spain).
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: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.