COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Gemcitabina Aurobindo Pharma Italia». (20A01087)
Estratto determina AAM/PPA n. 73 del 3 febbraio 2020 Si autorizza il seguente grouping di variazioni, relativamente al medicinale GEMCITABINA AUROBINDO PHARMA ITALIA: tipo IA, B.II.b.2a), aggiunta di un sito in cui si effettuano il controllo dei lotti/le prove;
tipo II, B.II.b.1z), aggiunta di un nuovo sito di produzione del bulk;
cambi al processo di produzione, batch size, e controlli in-process per adattarli al nuovo sito di produzione;
tipo IB, B.II.d.2d), aggiunta di una procedura alternativa per il test dell'endotossina batterica al fine di testare la «Gemcitabina» 40 mg/ml soluzione concentrata per infusione nel nuovo sito di produzione del prodotto finito;
tipo IB, B.II.e.4c), modifica della forma o delle dimensioni dei contenitori - medicinale sterile;
tipo IAIN n. 2), B.II.b.1a), aggiunta di due nuovi siti di confezionamento secondario;
tipo IAIN , n. 2), B.II.b.2c)1, aggiunta di due nuovi siti di rilascio lotti: Generis Farmacêutica, S.A., Rua João de Deus n. 19, Venda Nova, 2700-487 Amadora, Portogallo (PT), per la «Gemcitabina» 40 mg/ml soluzione concentrata per infusione;
APL Swift Services, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000, Malta (MT), per la «Gemcitabina» 40 mg/ml soluzione concentrata per infusione;
tipo IAIN , B.II.b.2c)2, aggiunta di nuovo sito di rilascio dei lotti compresi il controllo dei lotti/le prove: Idifarma Desarrollo Farmaceutico S.L., Poligono Mocholi', C/Noain, n. 1 de Noain, 31110 (Navarra), Spagna (ES), come per la...
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