ROTTAPHARM S.P.A. - Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano apportata ai sensi d.lgs. 219/2006 e s.m.i.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano apportata ai sensi d.lgs. 219/2006 e s.m.i. Titolare A.I.C.: ROTTAPHARM S.p.A. - Galleria Unione, 5 - 20122 Milano Ai sensi della determinazione AIFA 18 Dicembre 2009, si informa dell'avvenuta approvazione delle seguenti variazioni: Specialita' medicinale: TERAFLUSS - Confezioni e numeri A.I.C.: "5 mg compresse" 14 compresse divisibili (A.I.C.: 035046022) "5 mg compresse" 28 compresse divisibili (A.I.C.: 035046046) "2 mg compresse" 30 compresse divisibili (A.I.C.: 035046034) Codice Pratica: N1A/2012/2122 conclusa in silenzio assenso in data 11.12.2012 Tipologia variazione: IA.B.I.b.1.c) Tipo di Modifica: aggiunta del parametro di specifica particle size e del corrispondente metodo di prova per il principio attivo Terazosina cloridrato. Codice Pratica: N1A/2012/2276 conclusa in silenzio assenso in data 28.12.2012 Tipologia variazione: IA.A.5.b) Tipo di Modifica: Modifica dell'indirizzo dell'officina responsabile della produzione del prodotto finito in FINE FOODS &
PHARMACEUTICALS N.T.M. S.p.A., Via R. Follereau, 25 - 24027 Nembro (BG) Specialita' medicinale: UGUROL - Confezioni e numeri A.I.C.: "500 mg/5 ml soluzione iniettabile per uso endovenoso, per uso orale e locale" 5 fiale (A.I.C. 021458029) Codice Pratica: N1B/2012/2505 conclusa in silenzio assenso in data 23.12.2012 Tipologia variazione: Grouping IB.B.II.d.2.d);
IB.B.II.d.2.d) Tipo di Modifica: sostituzione del metodo TLC per la determinazione delle sostanze correlate (bis-compound) e modifica dei metodi HPLC per la determinazione del titolo dell'acido tranexamico e delle sostanze correlate (cis-compound) con un nuovo metodo HPLC, al fine di avere un metodo comune, per titolo e sostanze correlate...
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