Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00241&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved V&A 2591/2014 December 9, 2014 # the determines are authorized the following variation: reduction of the content of the excipient methyl-parahydroxybenzoate (methyl paraben) from 1.62 mg/ml and 1.22 mg/ml in the finished product in relation to medicine VALPRESSION and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: # IF/H/0406/007/WS/127-# IF/H/xxxx/WS/032 type of variation: b. II. a. 3 b. 2) change in composition (ingredients) of the finished product. The other ingredients. Qualitative and quantitative changes in one or more ingredients that can have a significant impact on the safety and efficacy of the product.
Mah: A. Menarini Pharmaceutical Industries Gathered S.R.L.
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.
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