AUROBINDO PHARMA (ITALIA) S.R.L. - Modifiche secondarie di un'AIC di medicinali per uso umano apportate ai sensi del decreto legislativo 29 dicembre 2007, n. 274 e del regolamento (CE) n. 1234/2008 ai seguenti medicinali
Modifiche secondarie di un'AIC di medicinali per uso umano apportate ai sensi del decreto legislativo 29 dicembre 2007, n. 274 e del regolamento (CE) n. 1234/2008 ai seguenti medicinali OLANZAPINA AUROBINDO 2,5 mg/5 mg/10 mg compresse;
Confezioni e numeri di A.I.C.: Tutte le confezioni autorizzate;
Codice Pratica: C1A/2012/2743;
Procedura n. PT/H/0487/001-002 &
004/IA/002 conclusa in data 23/12/2012;
Numero e tipologia di Variazione: Tipo IA n. A.5.b. Modifica del nome e dell'indirizzo della sede legale di un sito di produzione per il confezionamento secondario (da: Segetra S.A.S. Via Milano 85, 20078 San Colombano al Lambro (MI) a Segetra Pharma S.r.l. Via Andrea Appiani 21, 20052 Monza (MB). OMEPRAZOLO AUROBINDO 10mg, 20mg e 40mg capsule rigide gastroresistenti;
Confezioni e numeri di AIC: Tutte le confezioni autorizzate;
Codice Farmaco n. 041176/M;
Codice Pratica: C1A/2013/5;
Procedura n. MT/H/0120/001-003/IA/006 conclusa in data 10/02/2013;
Numero e tipologia di Variazione: Tipo IA n. B.III.1.a.2: Presentazione del Certificato di conformita' alla Farmacopea Europea aggiornato R0-CEP 2008-075-Rev 01, della sostanza attiva Omeprazolo, del produttore autorizzato Aurobindo Pharma Limited (Unit XI)...
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