COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Perindopril e Indapamide Teva». (18A01964)
Estratto determina AAM/PPA n. 223/2018 del 6 marzo 2018 L'autorizzazione all'immissione in commercio e' rinnovata con validita' illimitata dalla data del rinnovo europeo 17 ottobre 2017 (NL/H/2467/001-002/R/001). Sono autorizzate, altresi', le variazioni di tipo IB: C.I.3.z) aggiornamento del riassunto delle caratteristiche del prodotto, del foglio illustrativo ed etichettatura a seguito della conclusione della procedura PSUSA/00002354/201510 e adeguamento al QRD Template (NL/H/2467/001-002/IB/016) e C.I.3.z) C.I.z) aggiornamento del riassunto delle caratteristiche del prodotto, del foglio illustrativo a seguito della conclusione della procedura PSUSA/00000536/201604 e aggiunta dell'effetto indesiderato «angiodema intestinale» (con frequenza molto rara) (NL/H/2467/001-002/IB/017/G) relativamente al medicinale: PERINDOPRIL E INDAPAMIDE TEVA (041940). Dosaggio/Forma farmaceutica: «2,5 mg/0,625 mg compresse rivestite con film» (tutte le confezioni);
5 mg/1,25 mg compresse rivestite con film
(tutte le confezioni). Titolare A.I.C.: Teva italia S.r.l., con sede legale e domicilio fiscale in piazzale Luigi Cadorna, 4 - 20123 - Milano (Italia) - Codice fiscale/partita iva 11654150157. Le modifiche devono essere apportate per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determinazione mentre per il foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla medesima data. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio...
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