Avviso di rettifica
Errata corrige
Errata corrige
Modifiche secondarie di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. Modifiche apportate ai sensi del D.Lgs. n. 219/2006 e s.m.i. e del Regolamento CE n. 1234/2008 Codice Pratica: N1B/2020/854 Numero di Procedura Europea: IE/H/xxxx/WS/126. Specialita' medicinale: GASTROMIRO 61,2% Soluzione (AIC 026899) Titolare: Bracco Imaging SpA, Via Egidio Folli 50, 20134 Milano Tipologia variazione: Grouping 15 variazioni: 4 di Tipo 1 B e 11 di tipo 1 A: n. 2 Tipo 1 B B.II.a.3.z Changes in the composition (excipients) of the finished product: 1) Replacement of citric acid monohydrate with citric acid anhydrous 2) Replacement of Water for injection with Purified Water Tipo 1 B B.II.b.1.e Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product: Manufacturing site: E-Z-EM Tipo 1 B B.II.b.4.a Change in the batch size (including batch size ranges) of the finished product: Batch size E-Z-EM: 500 L Tipo 1Ain B.II.b.1.a Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product: Secondary packaging site: E-Z-EM Tipo 1 Ain B.II.b.1.b Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product: Primary packaging site: E-Z-EM Tipo 1 A B.II.b.2. a Change to importer, batch release arrangements and quality control testing of the finished product: Quality Control testing: E-Z-EM Tipo 1 Ain B.II.b.2.c.1 Change to importer, batch release arrangements and quality control testing of the finished product: Batch release: Bracco Imaging spa n. 2 Tipo IA B.II.b.3.a Change in the manufacturing process of the finished product, including an intermediate used in the manufacture of the finished product - Minor change: 1) Nitrogen no longer used - E-Z-EM 2) Use of 3 µm instead of 0.2 µm filter - E-Z-EM n. 2 Tipo IA B.II.b.5.a Change to in-process tests or limits applied during the manufacture of the finished product -Tightening of in-process limits: 1) IPC pH limit: 4.0-4.5 to 4.00-4.25 range - E-Z-EM 2) IPC Fill Limits: 20.5-21.5 mL, 51.0-53.0 mL and 101.5-104.5 mL - E-Z-EM n. 3 Tipo IA B.II.d.2.a. Change in test procedure for the finished product - Minor changes to an approved test procedure: 1) Solvent used for Assay of "Sodium saccharinate dihydrate and Sodium cyclamate" -E-Z-EM 2) Free Aromatic Amine test method with manual modality- E-ZEM 3) Biological controls test - E-Z-EM I lotti gia' prodotti alla data di pubblicazione in Gazzetta Ufficiale sono mantenuti in commercio fino alla data di scadenza indicata in etichetta. Un procuratore dott. Andrew Betournay TX21ADD3954