COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Tektrotyd» (17A01787)
Estratto determina PPA n. 134 del 16 febbraio 2017 Autorizzazione della variazione relativamente al medicinale TEKTROTYD E' autorizzata la seguente variazione: Aggiornamento del ASMF per il principio attivo HYNIC-[D-Phe1 ,Tyr3 -octreotide] sale di TFA del titolare e produttore piCHEM GmbH (piCHEM -Forschungs- und Entwicklungs GmbH, Kahngasse 20, 8045 Graz, Austria) dalla versione N. 2.0/12-2014 del dicembre 2014 alla versione numero 3.0/06-2016 di giugno 2016 relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo riconoscimento Procedura: DE/H/3726/001/II/001 Titolare AIC: Rotop Pharmaka AG Smaltimento scorte I lotti gia' prodotti possono...
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