Review Product Marketing Authorisation For Human Use «Dolofast».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01402&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 11, 2015 V&A # 244/2015 determines the authorized the following variation: 1. b B) change in the manufacturer of a raw material of a reagent or an intermediate product used in the manufacturing process of the active substance or review of the manufacturer of the active substance (possibly including the sites of quality control), for which you do not have a certificate of conformity to European Pharmacopoeia introduction of a manufacturer of the active substance with the support a ASMF (Master File of the active substance), relative to medicine DOLOFAST, shapes and packagings AIC # 029775018-"10% gel 50 g hose: Add a new active substance manufacturer supported by DMF-Shasun Pharmaceuticals Limited, as follows: part of ruling graphically Mah: BRACCO S.P.A. with registered office and tax domicile in Via Egidio Folli, 50, 20134-Milano (MI) Italy, (tax 00825120157) disposal stocks 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 April 14, 2014 # 371 of AIFA determines 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.