COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Tanzolan», con conseguente modifica stampati. (19A07416)
Estratto determina AAM/PPA n. 879/2019 del 29 ottobre 2019 L'autorizzazione all'immissione in commercio del medicinale: TANZOLAN (A.I.C. n. 043054). Dosaggio/forma farmaceutica: «15 mg capsule rigide gastroresistenti» (tutte le confezioni autorizzate);
30 mg capsule rigide gastroresistenti
(tutte le confezioni autorizzate). Titolare A.I.C.: S.F. Group S.r.l., con sede legale in via Tiburtina n. 1143, Roma - codice fiscale n. 07599831000. Codice procedura europea: DE/H/3931/001-002/R/001. Codice pratica: FVRMC/2017/57, con scadenza il 31 dicembre 2017 e' rinnovata con validita' illimitata e con conseguente modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura, a condizione che, alla data di entrata in vigore della presente determina, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Le modifiche devono essere apportate per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determina 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 successive modificazioni ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende avvalersi dell'uso complementare di lingue estere, deve darne preventiva comunicazione all'AIFA e tenere a...
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