COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Formodual». (19A05312)
Estratto determina AAM/PPA n. 630/2019 del 26 luglio 2019 Descrizione del medicinale, attribuzione n. A.I.C. e autorizzazione variazioni: e' autorizzata, con variazione Tipo IB B.II.e.5.d), l'immissione in commercio del medicinale FORMODUAL anche nelle forme farmaceutiche, dosaggi e confezioni di seguito indicate: Confezioni: «100 microgrammi/6 microgrammi polvere per inalazione» 1 inalatore in abs/pp da 180 dosi - A.I.C. n. 037778139 (base 10) 140WQV (base 32);
100 microgrammi/6 microgrammi polvere per inalazione
2 inalatori in abs/pp da 180 dosi - A.I.C. n. 037778141 (base 10) 140WQX (base 32);
100 microgrammi/6 microgrammi polvere per inalazione
3 inalatori in abs/pp da 180 dosi - A.I.C. n. 037778154 (base 10) 140WRB (base 32). Forma farmaceutica polvere per inalazione. Principio attivo beclometasone diproprionato e formoterolo fumarato. Sono, inoltre, autorizzate, relativamente alle sopraindicate confezioni, le conseguenti variazioni di seguito riportate: Tipo IA, B.II.b.3.a) - «Modifica del processo di fabbricazione del prodotto finito, incluso un intermedio utilizzato nella fabbricazione del prodotto finito: cambiamenti minori nel processo di fabbricazione». 2 Tipo IA, B.II.b.5.b) - «Modifica dei test in-process e dei limiti applicati durante la produzione del prodotto finito - aggiunta di un nuovo test e limite». 3 Tipo IA, B.II.d.1.c) - «Modifica dei parametri di specifica e/o dei limiti del prodotto finito - Aggiunta di un nuovo parametro di specifica alle specifiche con il relativo metodo di prova». 4 Tipo IA, B.II.d.2.a) - «Modifica della procedura di prova del prodotto finito - Modifiche minori a una procedura di prova approvata». Tipo IA, B.II.e.6.b) - «Modifica in qualsiasi parte del materiale di confezionamento (primario) non in contatto con il prodotto finito». Titolare A.I.C.: Promedica S.r.l., con sede legale e domicilio fiscale in via Palermo, 26/A - 43122 Parma, Italia, codice fiscale n. 01697370342. Codice procedura europea: DE/H/0872/02/IB/062/G. Codice pratica: C1B/2018/2728BIS...
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