Review Product Marketing Authorisation For Human Use "clodronate Abc».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01400&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 16, 2015 V&A # 298/2015 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 that has the supporting a ASMF (Master File of the active substance), in relation to the drug CLODRONATE ABC, shapes and packaging 100 mg/# 035129016-"AIC 3.3 ml injection" 6 vials of 3.3 ml, AIC # 035129028-100 mg/ml solution for injection "3.3" 12 vials of 3.3 ml, AIC # 035129030-"300 mg/10 ml solution for infusion" 6 vials: introduction of FARCHEMIA SRL as new producer for the active substance DISODIUM CLODRONATE as follows: measure in graphic form the active ingredient is controlled according to the specifications of the European Pharmacopoeia current edition. Retest period: 4 years.
MAh: ABC FARMACEUTICI S.P.A. with registered office and tax domicile in Corso Vittorio Emanuele II, 72, 10121-Torino (TO) Italy, (tax 08028050014) 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.