COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Clarens» e «Vessel». (16A01630)
Estratto determina V&A n. 367/2016 del 22 febbraio 2016 E' autorizzato il seguente grouping di variazioni: B.I.a.1.j) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Modifiche nelle misure riguardanti le prove di controllo della qualita' per un principio attivo biologico: sostituzione o aggiunta di un sito per il controllo/le verifiche dei lotti, anche attraverso metodi biologici/immunologici/immunochimica, B.I.b.2.d) Modifica nella procedura di prova di un principio attivo o di materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del principio attivo - Modifica sostanziale o sostituzione di un metodo di prova biologico, immunologico o immunochimico o di un metodo che utilizza un reattivo biologico per un principio attivo biologico, relativamente ai medicinali CLARENS e VESSEL, nelle forme e confezioni: CLARENS A.I.C. n. 026866069 - «600 uls/2 ml soluzione iniettabile» 10 fiale 2 ml A.I.C. n. 026866071 - «250 uls capsule molli» 50 capsule VESSEL A.I.C. n. 022629101 - «600 uls/2 ml soluzione iniettabile» 10 fiale da 2 ml A.I.C. n. 022629113 - «250 uls capsule molli» 50 capsule sostituzione del sito responsabile dell'esecuzione del test relativo alla determinazione dell'attivita' lipasemica sul sulodexide, principio attivo delle due specialita' medicinali in oggetto, «Vessel» e «Clarens», unitamente alla sostituzione del metodo relativo alla determinazione dell'attivita' lipasemica, come di seguito...
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