Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-10&atto.codiceRedazionale=15A00835&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved January 27, 2015 V&A # 117 determines the authorized the transfer of title of the marketing authorisations of the medicinal listed below so far registered in the name of the company Glaxosmithkline S.p.a. (tax ID # 00212840235) with registered office and tax domicile in Via a. Fleming n. 2, 37135-Verona (VR).
Package and number 1 g/025378023-5: A.I.C. «ml solution for injection 5 ml ampoules 5 ';
025378035-' 1 g/10 ml oral solution 10 ml vials 10 ';
025378062-' 1 g chewable tablets, 10 ' to society: Sigma-Tau Industrie Farmaceutiche Riunite S.p.a. (tax ID # 00410650584) with registered office and tax domicile in Shakespeare Avenue # 47, 00144-Rome (RM).
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 article 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.
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