Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-23&atto.codiceRedazionale=15A02097&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 24, 2015 V&A # 365/2015 of causes _ (authorization of changes concerning the medicine ZOLPREM) are authorized the following variation: approval of the Risk management Plan of Zolprem with its post-approval commitments concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How to: en/H/0188/001/II/007 type of variation: C.I. z Mah: LIFEPHARMA S.P.A.
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 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 published in the Official Gazette No. 101 of 03/05/2014.
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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