Review Product Marketing Authorisation For Human Use "levofloxacin B. Braun»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-21&atto.codiceRedazionale=15A00342&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved V&A 2587/2014 December 9, 2014 # the determines are authorized the following variation: Add manufacturer Chemo Iberica, S.A. C/Quintapalla 2, 4 ª Planta 28050 Madrid Spain (production site: Quimica, s.a. C/Dulcinea s/n 28805 Alcalá de Henares (Madrid Spain), possessing the ASMF (LV-QS2-EU-September 2013), concerning the active substance Levofloxacin hemihydrate, relatively to the medicine LEVOFLOXACINA b. BRAUN and authorised pack sizes the placing in Italy as a result of mutual recognition.
How to: ES/HR/0188/001/II/001.
Type of change: 1. b B) quality changes active ingredient production "Review of the manufacturer of a raw material, a reactive or an intermediate product used in the manufacturing process of the active substance or changing the manufacturer.
Mah: B. Braun Melsungen AG.
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: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.