NOVARTIS CONSUMER HEALTH S.P.A. - Modifiche secondarie dell'AIC di medicinali per uso umano, apportate ai sensi del d.lgs. 219/2006 e s.m.i.
Modifiche secondarie dell'AIC di medicinali per uso umano, apportate ai sensi del d.lgs. 219/2006 e s.m.i. Titolare: Novartis Consumer Health S.p.A., Largo U. Boccioni 1 - 21040 Origgio (VA) Ai sensi della determinazione AIFA 18 dicembre 2009, si informa dell'avvenuta approvazione delle seguenti modifiche, apportate in ai sensi del Regolamento 1234/2008/CE: Specialita' medicinale: GASTROLOC Confezioni: tutte - Codice A.I.C.: 038253/M Procedura di Mutuo Riconoscimento n. MRP n. NL/H/0728/001-002/IA/034 Codice pratica C1A/2012/2540 Tipo IAIN n. B.III.1.a.1: Presentazione di un nuovo certificato di conformita' alla monografia corrispondente della Farmacopea Europea (R0-CEP 2008-289-Rev 01) relativo al principio attivo pantoprazolo sodico sesquidrato, da parte di un fabbricante gia' approvato (Hetero Drugs Limited - India). Specialita' medicinale: TRIPTALIDON Confezioni: tutte - Codice A.I.C.: 038897/M Procedura di Mutuo Riconoscimento n. MRP n. NL/H/0629/001-002/IA/019/G Codice pratica...
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