COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Timoptol» (19A03559)
Estratto determina AAM/PPA n. 397 del 20 maggio 2019 Autorizzazione delle variazioni: Grouping di variazioni di tipo II: B.II.b.1.a), B.II.b.1.z), B.II.b.2.c.1), B.II.b.2.c.2), B.II.e.1.b.2), relativamente al medicinale TIMOPTOL;
Codice pratica: VN2/2018/146. Sono autorizzate le seguenti variazioni: aggiunta del sito Santen Pharmaceutical Co Ltd. Noto Plant, Ishikawa, Japan per la produzione del prodotto finito, confezionamento primario e secondario;
con relative modifiche al processo di produzione, dimensione del lotto e controlli in-process (solo per la specialita' «Timoptol»);
aggiunta dei seguenti siti per il confezionamento secondario: Arvato Distribution GmbH, Nordrhein-Westfalen, Germany;
Manufacturing Packaging Farmaca (MPF) B.V., Heerenveen, Netherlands Santen Oy, Tampere, Finland;
aggiunta dei seguenti siti responsabili dell'importazione, esclusi il controllo dei lotti/le prove: Arvato Distribution GmbH, Nordrhein-Westfalen, Germany;
Manufacturing Packaging Farmaca (MPF) B.V., Heerenveen, Netherlands;
aggiunta di un fabbricante responsabile dell'importazione e rilascio lotti, inclusi il controllo dei lotti/le prove: Santen Oy, Tampere, Finland;
sostituzione del confezionamento primario da Ocumeter Plus flacone con dosatore con un nuovo confezionamento primario type-6 flacone. Si autorizza inoltre la modifica della descrizione delle confezioni, per adeguamento allo standard terms, da: A.I.C. n. 024278107 «0,25% collirio,soluzione» flacone da 5 ml con dosatore oftalmico Ocumeter Plus;
A.I.C. n. 024278121 «0,50% collirio,soluzione» flacone da 5 ml con dosatore oftalmico Ocumeter Plus, a: A.I.C. n. 024278107...
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