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. Titolare Autorizzazione Immissione in Commercio: 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: CISTALGAN Confezioni e numeri Autorizzazione Immissione In Commercio: "200 mg + 250 mg compresse rivestite" 30 compresse (Autorizzazione Immissione in Commercio: 022228074) "200 mg + 1 g supposte" 6 supposte (Autorizzazione Immissione in Commercio: 022228086) conclusa in silenzio assenso in data 25.04.2013 Tipologia variazione: IB.C.I.7.a) Tipo di Modifica: Eliminazione della forma farmaceutica supposte Specialita' medicinale: UGUROL Confezioni e numeri Autorizzazione Immissione In Commercio: "250 mg compresse" 20 compresse (Autorizzazione Immissione in Commercio: 021458017) "500 mg/5 ml soluzione iniettabile" 5 fiale (Autorizzazione Immissione in Commercio: 021458029) Codice Pratica: N1A/2013/388 conclusa in silenzio assenso in data 17.04.2013 Tipologia variazione: IA.A.4 Modifica apportata: Modifica dell'indirizzo del detentore del Drug Master File del principio attivo Acido Tranexamico in ASAHI KASEI FINECHEM CO LTD, Nakanoshima-dai building, 3-3-23, Nakanoshima, Kita-ku - 530-6130 Osaka (Giappone) Specialita' medicinale: ALTAN Confezioni e numeri Autorizzazione Immissione Commercio:"30mg compresse rivestite con film" 20 compresse Autorizzazione Immissione Commercio: 026419010 Codice Pratica: N1B/2013/290 conclusa in silenzio assenso in data 10.04.2013 Tipologia...
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