COMUNICATO - Rinnovo e modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ramipril Zentiva». (17A02884)
Estratto determina AAM/PPA n. 365/2017 del 6 aprile 2017 L'autorizzazione all'immissione in commercio della specialita' medicinale RAMIPRIL ZENTIVA (A.I.C. n. 037692) e' rinnovata, con validita' illimitata, dalla data del rinnovo europeo. Sono autorizzate le seguenti variazioni: Modifica paragrafi 4.5 del riassunto delle caratteristiche del prodotto e del paragrafo 2 del foglio illustrativo per l'aggiornamento del CCDS relativo all'interazione con racecadotril. Modifica paragrafi 4.4 e 4.5 del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo per inclusione dell'interazione con Inibitori di mTOR e Inibitori di DPP - IV. Modifica paragrafi 4.5 e 4.8 del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo per implementazione delle raccomandazioni del CMDh. Modifiche minori relativamente al medicinale «Ramipril Zentiva», nelle seguenti forme e confezioni: A.I.C. n. 037692023 - «2,5 mg compresse» 28 compresse divisibili in blister PVC/AL;
A.I.C. n. 037692035 - «5 mg compresse» 14 compresse divisibili in blister PVC/AL;
A.I.C. n. 037692047 - «10 mg compresse» 28 compresse divisibili in blister PVC/AL. Procedure: DE/H/2626/001-003/R/001 - DE/H/2626/001-003/II/019 - DE/H/2626/001-003/IB/015 - DE/H/2626/001-003/IB/018. Titolare A.I.C.: Zentiva Italia S.r.l. Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determinazione, al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura. 2. In ottemperanza all'art. 80...
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