Review Product Marketing Authorisation For Human Use Broncho Vaxom «»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01479&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 10, 2015 V&A # 236 of determines The ownership of the marketing authorisations of the below listed medicinal product until now registered in the name of the company Takeda Italy S.p.a., with registered office in Via Elio Vittorini, 129, Rome, with tax identification code 00696360155.
Medicinal Product: Broncho Vaxom.
AIC packs: 026029013-"adult capsules" 10 capsules;
026029037-"children capsules" 10 capsules;
026029064-"adult capsules" 30 capsules;
026029088-"children capsules" 30 capsules;
026029090-"children granules for oral suspension" 30 sachets;
026029102-"children granules for oral suspension" 10 sachets;
It is now transferred to the company: OM Pharma SA, established in Rua Da Quinta Grande 2, Industry, Amadora, Portugal.
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.