Organon Italia - S.p.a. Sede legale in Roma, via Ostilia n. 15 Capitale sociale Euro 5.720.000,00 Codice fiscale n. 00405640582
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano
Titolare: N.V. Organon, Kloosterstraat 6, 5349 AB Oss (Olanda). Rappresentante in Italia: Organon Italia S.p.a., via Ostilia n. 15, 00184 Roma.
Comunicazione Agenzia italiana del farmaco del 2 febbraio 2007.
Codice pratica: NIA/06/1273BIS.
Specialita' medicinale: ORGARAN.
Confezione e numero di A.I.C.:
'750 U anti-XA soluzione iniettabile' 20 fiale 0,6 ml - A.I.C. n. 028462012.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003 e successive modifiche: 28. Modifica di parte del condizionamento primario: da fiala easy cut (EC) con vernice dell'anello di rottura contenente metalli pesanti, a fiala one point cut (OPC) con vernice dell'anello di rottura esente da metalli pesanti.
Comunicazione Agenzia italiana del farmaco del 6 dicembre 2006
rettificata il 22 febbraio 2007. Codice pratica: N1A/06/1239B1S.
Specialita' medicinale: DECA DURABOLIN.
Confezioni e numeri di A.I.C.:
'25 mg/1 ml soluzione iniettabile per uso intramuscolare' 1 fiala da 1 ml - A.I.C. n. 017712011;
'50 mg/1 ml soluzione iniettabile per uso intramuscolare' 1 siringa preriempita da 1 ml - A.I.C. n. 017712035.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 25.b.1 Modifica per ottemperare all'aggiornamento della relativa monografia (n. 1992) della Farmacopea europea per il principio attivo Nandrolone Decanoato.
Titolare A.I.C.: Organon Italia S.p.a., V. Ostilia n. 15, 00184 Roma.
Comunicazione Agenzia...
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