Review Product Marketing Authorisation For Human Use «Zimacrol»

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Zimacrol»

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-10&atto.codiceRedazionale=15A00833&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 27, 2015 V&A # 114 of Medicine determines: ZIMACROL.
It authorized the transfer of title of the marketing authorisations of the medicinal listed below so far registered in the name of the company Benedetti & co. S.p.A. (tax number 01670410479) with registered office and tax domicile in via Bolognese, 250-51020 Pistoia.
Package: A.I.C. # 039039019-' 500 mg film-coated tablets» 3 tablets.
To society: S.F. Group S.r.l. (tax number 07599831000) with registered office and tax domicile in via Beniamino Segre, 59-00134 Rome.
The marketing authorisation holder should make the changes, the date of entry into force of determination, referred to in this excerpt, the summary of product characteristics, no later than six months from the same date the package leaflet and labelling.
Inventory disposal Both lots already have products on the date of entry into force of determination, referred to in this excerpt that the batches produced during the period referred to in art. 2, paragraph 1, of the same determination, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.