PFIZER ITALIA S.R.L. -
Modifiche secondarie di un'autorizzazione all'immissione in commercio di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i. Ai sensi della Determinazione AIFA 25 agosto 2011 si informa dell'avvenuta approvazione delle seguenti modifiche apportate in accordo al regolamento (CE) 1234/2008: Specialita' medicinale: LATANOPROST E TIMOLO PFIZER Confezioni e numeri di AIC: AIC n. 040931(tutte le confezioni)/M Titolare: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice pratica: C1B/2012/2471 Variazione IB n. A.2.b - Modifica della denominazione del medicinale in Portogallo da Latanoprost/Timolol Parke Davis a Latanoprost/Timolol Pfizer (Procedura n. SE/H/1074/001/IB/003). Specialita' medicinale: RELPAX 20mg e 40mg compresse rivestite con film Confezioni e numeri AIC: 035307(tutte le confezioni)/M Titolare: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice pratica: C1B/2012/3098 Grouping di variazioni di Tipo IA e IB: Tipo IB - B.II.b.1 e) Aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito (Pfizer Italia S.r.l., Localita' Marino del Tronto, 63100 Ascoli Piceno);
Tipo IA - B.II.b.2 a) Modifica delle modalita' di liberazione dei lotti e delle prove di controllo qualitativo del prodotto finito;
Tipo IA - B.II.b.3 a) Modifica nel procedimento di fabbricazione del prodotto finito;
Tipo IA - B.II.b.4 a) Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito (Procedura n. UK/H/0432/01-02/IB/045/G) Specialita' medicinale: TRIMINULET...
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