Review Product Marketing Authorisation For Human Use "azithromycin Pfizer».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01396&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 11, 2015 2015 # 242/V&A 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, relative to medicine AZITHROMYCIN PFIZER, shapes and wrappings A.I.C.: «250 mg capsule» 6 capsules-A.I.C. # 027897014;
«200 mg/5 ml powder for oral suspension 1 bottle 1500 mg-A.I.C. ' # 027897026;
«500 mg film-coated tablets» 3 tablets-A.I.C. # 027897040;
«200 mg/5 ml powder for oral suspension 1 ' 600 mg-bottle A.I.C. # 027897053;
«100 mg powder for oral suspension» 3 sachets-A.I.C. # 027897065;
«150 mg powder for oral suspension» 3 sachets-A.I.C. # 027897077;
«200 mg powder for oral suspension» 3 sachets-A.I.C. # 027897089;
«300 mg powder for oral suspension» 3 sachets-A.I.C. # 027897091;
«400 mg powder for oral suspension» 3 sachets-A.I.C. # 027897103;
«AVIUM 600 mg film-coated tablets» 8 tablets-A.I.C. # 027897115;
«500 mg powder for solution for infusion» 1 vial-A.I.C. # 027897127;
introduction of new specification limits for degradation products of azithromycin, count, known and unknown, and the corresponding analytical methods (HPLC).
A.I.C. holder: Pfizer Italy S.r.l. with registered office and tax domicile in via Isonzo # 71, 04100 Latina-Italy, (tax code # 06954380157).
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.