Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00304&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved V&A 2650/2014 December 16, 2014 # the determines (authorization of the change relatively to the drug Fluarix) are authorized the following variation: inserting RMP version 2 of Fluarix.
The change does not involve review of printed materials regarding the drug FLUARIX and authorised pack sizes the placing in Italy following the mutual recognition procedure.
Procedures: DE/H/0124/001/II/100 type of variation: C.I. z Mah: GLAXOSMITHKLINE 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 paragraph 5 of the AIFA 14/04/2014 # 371 of Determines 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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