COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ursolisin» (13A03526)
Estratto determinazione V &
A n. 483 del 2 aprile 2013 Medicinale: URSOLISIN. Titolare A.I.C.: Magis Farmaceutici S.p.A. via Cacciamali, 34- 36-38 - 25125 Brescia, codice fiscale 00312600174. Variazione A.I.C.: B.I.d.1) Modifica del periodo di ripetizione della prova/periodo di stoccaggio o delle condizioni di stoccaggio della sostanza attiva quando non vi e' certificato di conformita' alla farmacopea europea che copre il periodo di ripetizione della prova nel quadro del fascicolo approvato;
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Periodo di ripetizione della prova/periodo di stoccaggio;
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Estensione o introduzione di un periodo di ripetizione della prova/di stoccaggio sulla base di dati in tempo reale;
B.III.1) Presentazione di un certificato di conformita' alla farmacopea europea nuovo o aggiornato: a) Certificato di conformita' alla monografia corrispondente della farmacopea europea;
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Nuovo certificato presentato da un nuovo fabbricante (sostituzione o aggiunta). Adeguamento Standard Terms. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata. E' autorizzata la modifica relativa alla sostituzione del produttore di principio attivo acido ursodesossicolico con il nuovo sito ICE S.p.A. titolare del CEP R0-CEP 2005-198-Rev 03, unitamente all'aggiornamento della sezione 3.2.A.2 «Adventitious Agent Safety Evaluation» per tale produttore e all'inserimento del re-test period della sostanza attiva fornita dal nuovo produttore, come di seguito riportato: Parte di provvedimento in formato grafico relativamente alla Specialita' Medicinale indicata in oggetto e alle confezioni sotto elencate: 025430101 - «300 mg capsule rigide» 20 capsule;
025430099 - «300 mg capsule rigide» 10 capsule;
025430087 - «150 mg capsule rigide» 40 capsule;
025430075 - «150 mg...
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