COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Trimeton» (18A04133)
Estratto determina AAM/PPA n. 468/2018 del 18 maggio 2018 Si autorizzano le seguenti variazioni: per la VN2/2017/77: n. 1) Tipo II, B.II.e.1 b) 2: sostituzione del tipo di fiala usata nel confezionamento;
n. 7) Tipo IB, A.7 - B.II.b.1 f) - B.II.b.3 a) - B.II.d.1 c) - B.II.d.2 d) - B.II.d.2 d) - B.III.1a) 3: eliminazione del sito di produzione, confezionamento, controllo e rilascio del prodotto finito: Schering-Plough Labo n.v., Industriepark, 30, B- 2220 Heist-op-den-Berg, Belgium ed eliminazione del sito di confezionamento secondario UPS Healthcare Italia S.r.l, via del Lago, 1/3 20060 Liscate, (MI) Italia. Sostituzione del sito in cui sono effettuate tutte le operazioni di produzione, ad eccezione del rilascio e controllo dei lotti e del confezionamento secondario: Cenexi -2, rue Louis Pasteur, 14200 Herouville St.-Clair France con il sito Doppel Farmaceutici Srl, via Volturno, 48 - Quinto De'Stampi - 20089 Rozzano, Milano, Italia. Aggiunta sul prodotto finito del test delle sostanze correlate (sia al rilascio che alla shelf life) con i relativi limiti. Sostituzione dei metodi analitici per i test titolo e colorazione sul prodotto finito. Eliminazione dello step di lavaggio e sterilizzazione delle fiale vuote. Sostituzione del produttore di API clorfenamina maleato Schering-Plough (Avondale) Company LTD. - Rathdrum CO. Wickow - Ireland con il produttore Kongo Chemical Co., Ltd JP 930-0912 Toyama City dotato del CEP R1-CEP 2006-151-rev00;
n. 2) Tipo IAin, B.II.b.1 a) - B.II.b.2 c)2: sostituzione del sito di confezionamento secondario, di controllo e rilascio del prodotto finito Cenexi -2, rue Louis Pasteur, 14200 Herouville St.-Clair France con il sito Doppel Farmaceutici srl, via Volturno, 48 - Quinto De'Stampi - 20089 Rozzano, Milano, Italia;
n. 5) Tipo IA, B.II.d.1...
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