COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Morelac» (18A04971)
Estratto determina AAM/PPA n. 623/2018 del 27 giugno 2018 Si autorizza la seguente variazione, Tipo II: B.I.a.1e) - Aggiunta del produttore Proge Farm Srl, via Bovio 6 - Novara, per la produzione dei ceppi batterici Lactobacillus acidophilus P 18806, Lactobacillus delbrueckii P 18805 e Streptococcus thermophilus P 18807, che costituiscono la sostanza attiva. La variazione e' relativa alla specialita' medicinale MORELAC, nella forma e confezione autorizzata all'immissione in commercio in Italia a seguito di procedura nazionale di seguito elencata: A.I.C. n. 034966010 - «polvere per sospensione orale» 10 bustine. Codici pratica: VN2/2017/368. Titolare A.I.C...
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