ALFA WASSERMANN S.P.A. -
Modifiche secondarie di autorizzazioni all'immissione in commercio di Specialita' medicinali per uso umano - Modifiche apportate ai sensi del decreto legislativo n. 219/2006 e s.m.i., della determinazione 25 agosto 2011 e del Regolamento 1234/2008/CE Titolare: ALFA WASSERMANN S.p.A. Specialita' medicinale: QUATROFEN Confezioni: 12, 25, 50, 75 e 100 mcg/ora cerotti transdermici - AIC n. 037783/M, tutte le confezioni registrate. Codice pratica: C1A/2013/746 - Grouping di 5 variazioni Tipo IA/IB: 2 variazioni IA IN-A.1 Cambio del nome del titolare AIC (Cipro e Spagna);
2 variazioni IA IN-A.5.a Modifica ragione sociale di un fabbricante del prodotto finito, responsabile del rilascio lotti (da: Nycomed Takeda a: Takeda Pharma A/S, medesimo indirizzo;
da: Nycomed GmbH: Takeda GmbH, medesimo indirizzo);
variazione Tipo IB n. B.III.1.a) 2 Deposito CEP aggiornato per un produttore autorizzato (Cedarburg Pharmaceuticals, Inc.: CEP: R1-CEP 2005-044-Rev 01). Specialita' medicinale: DICLOREUM Confezione e numero di A.I.C.: 3% schiuma cutanea, contenitore sotto pressione" - AIC n. 024515191. Codice pratica...
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