COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Lacteol» (18A05533)
Estratto determina AAM/PPA 712/2018 del 27 luglio 2018 Autorizzazione delle variazioni: B.I.a.2. Modifiche nel procedimento di fabbricazione del principio attivo;
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La modifica riguarda una sostanza biologica/immunologica o l'utilizzo di una sostanza derivata chimicamente diversa nella fabbricazione di una sostanza biologica/immunologica, tale da avere un impatto significativo sulla qualita', la sicurezza e l'efficacia del medicinale e che non e' collegata a un protocollo relativamente al medicinale LACTEOL, nelle forme e confezioni autorizzate all'immissione in commercio. Titolare AIC: Bruschettini S.r.l. Numero pratica: VN2/2017/391. Smaltimento scorte I lotti gia' prodotti possono essere...
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