Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-21&atto.codiceRedazionale=15A00311&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved December 16, 2014 2014 # 2662/V&A of determines are authorized the following variation: introduction of new risk management plan, in relation to the medicine TELMISARTAN ZENTIVA and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: DE/H/3123/001-003/II/010.
Types of variation: c. I z) other variation.
A.I.C. Holder:. Zentiva Italy 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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