Avviso di rettifica
Errata corrige
Errata corrige
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifiche apportate ai sensi del D.Lgs. n. 219/2006 e s.m.i. Titolare: Recordati Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 - Milano. Specialita' Medicinale: LOMEXIN Confezioni e Numeri di AIC: 2% crema - tubo 30 g (AIC n. 026043012) e 2% crema vaginale - tubo 78 g con 1 applicatore (AIC n. 026043277) Specialita' Medicinale: FALVIN Confezioni e Numeri di AIC: 2% crema - tubo 30 g (AIC n. 025982012) e 2% crema vaginale - tubo 78 g con 1 applicatore (AIC n. 025982226) Modifiche apportate in accordo al Regolamento 1234/2008/CE e s.m.i. Codice pratica: N1B/2021/822 Grouping of variations costituito da: B.II.b.3.a Type IB: Minor change in the manufacturing process (Change of the temperature in the preparation of fenticonazole nitrate solution from 80°C to 75°C). B.II.b.3.a Type IB: Minor change in the manufacturing process (Change of the quantity of purified water added for the preparation of the aqueous phase from 150 kg to 140 kg). B.II.b.3.a Type IB: Minor change in the manufacturing process (Addition of the target temperature of not lower than 70°C during the preparation of the emulsion). B.II.b.3.a Type IB: Minor change in the manufacturing process (Change of the final temperature of the bulk cream at the end of cooling phase from 40°C to 27°C). B.II.b.3.a Type IB: Minor change in the manufacturing process (Addition of a reference cooling time (150 minutes) at the end of emulsifying operation unit). B.II.b.5.b Type IA: Addition of a new in-process test and limit (Addition of the appearance of fenticonazole nitrate solution preparation after dissolution). B.II.b.5.b Type IA: Addition of a new in-process test and limit (Addition of the appearance of disodium edetate solution preparation after dissolution). B.II.b.5.b Type IA: Addition of a new in-process test and limit (Addition of the bulk final weight after the addition of the pre-heated water in emulsion preparation). B.II.b.5.b Type IA: Addition of a new in-process test and limit (Addition of the closure integrity test for the tubes at the end of filling phase). B.II.b.5.b Type IA: Addition of a new in-process test and limit (Addition of the closure suitability test for the boxes at the end of secondary packaging). B.II.b.3.z Type IB: Minor change in the manufacturing process (Addition of the holding time for the bulk cream after the cooling step up to the end of the filling step). I lotti gia' prodotti sono mantenuti in commercio fino alla data di scadenza indicata in etichetta. Decorrenza delle modifiche: dal giorno successivo alla data della pubblicazione in Gazzetta Ufficiale. Un procuratore dott.ssa Annarita Franzi TX21ADD8384