Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-09&atto.codiceRedazionale=15A00798&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved January 14, 2015 V&A # 29/2015 of Procedure determines EU #: 001-002/1806/DK/H/II/013.
Type II variation: B.I.b. 1 z).
Are authorized the following variation: eliminating the bulk size test by specific parameters of the active substance and elimination of note about the test for microbial contamination.
With respect to medicinal product: PAROXETINE PFIZER and at authorised pack sizes the placing in Italy following the mutual recognition procedure.
A.I.C. holder: Pfizer 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 subparagraph 5 of determines AIFA n. 371 of 14/04/2014 published in the Official Journal No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.
Search Translated Laws of Italy