COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Spiramicina 5% liquido chemifarma per uccelli da gabbia e da voliera e colombi viaggiatori». (19A01490)
Estratto provvedimento n. 80 dell'8 febbraio 2019 Medicinale veterinario: SPIRAMICINA 5% LIQUIDO CHEMIFARMA per uccelli da gabbia e da voliera e colombi viaggiatori. Confezioni: A.I.C. n. 103425 - Tutte. Titolare A.I.C.: Chemifarma S.p.A., via Don Eugenio Servadei n. 16 - 47122 Forli'. Oggetto del provvedimento: raggruppamento di variazioni di tipo: IA, A: soppressione dei siti di fabbricazione per un principio attivo, un prodotto intermedio o finito, un sito di confezionamento, un fabbricante responsabile del rilascio dei lotti, un sito in cui si svolge il controllo dei lotti o un fornitore di materia prima, di un reattivo o di un eccipiente (se precisato nel fascicolo);
IB, B.III.1.a.3: presentazione di un certificato di conformita' alla farmacopea europea nuovo o aggiornato, o soppressione di un certificato alla farmacopea europea: per un principio attivo, per una materia prima/un reattivo/una sostanza intermedia utilizzati nel procedimento di fabbricazione del principio attivo, per un eccipiente. Certificato di conformita' alla monografia corrispondente della farmacopea europea. Nuovo certificato presentato da un nuovo fabbricante (sostituzione o aggiunta). Si autorizzano le variazioni come di seguito descritte: soppressione del sito Laboratorio vaccinogeno Pagnini per le attivita' di fabbricazione...
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