Review Agency For Marketing Authorisation For Human Use «Taigalor» And «Xefo».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio deimedicinali per uso umano «Taigalor» e «Xefo».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-10&atto.codiceRedazionale=15A00834&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 27, 2015 V&A # 113 determines the authorized the transfer of title of marketing authorisation of medicines following until now registered in the name of the company Nycomed Italy S.r.l. (tax code no. 04086080969) with registered office and tax domicile in Via Elio Vittorini # 129, 00144-Rome (RM).
Medicine: TAIGALOR.
Package and 029304033-8 A.I.C. number: «mg film-coated tablets» 30 tablets in PVC/PVDC/AL;
029304072-' 8 mg/2 ml powder and solvent for injectable solution 1 vial 1 Vial powder and solvent ";
029304084-' 8 mg/2 ml powder and solvent for solution for injection» 10 vials powder and 10 vials solvent;
029304096-' 8 mg/2 ml powder and solvent for injectable solution vial 5 vials powder + 5 ' solvent;
Medicine: XEFO.
Package and 029313032-8 A.I.C. number: «mg film-coated tablets» 30 tablets in PVC/PVDC/AL;
029313071-' 8 mg/2 ml powder and solvent for injectable solution vial 5 Vials powder and 5 ' solvent;
029313095-' 8 mg/2 ml powder and solvent for solution for injection» 10 vials powder and 10 vials solvent;
029313107-' 8 mg/2 ml powder and solvent for injectable solution 1 vial 1 vial powder and solvent ";
029313119-' Rapid 8 mg film-coated tablets» 6 tablets in AL/AL;
029313121-' Rapid 8 mg film-coated tablets» 10 tablets in AL/AL;
029313133-' Rapid 8 mg film-coated tablets» 20 tablets in AL/AL;
029313145-' Rapid 8 mg film-coated tablets» 30 tablets in AL/AL;
029313158-' Rapid 8 mg film-coated tablets» 50 tablets in AL/AL;
029313160-' Rapid 8 mg film-coated tablets» 100 tablets in AL/AL;
029313172-' Rapid 8 mg film-coated tablets» 250 tablets in AL/AL to society: Takeda Italy S.p.a. (tax code # 00696360155) with registered office and tax domicile in Via Elio Vittorini # 129, 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.