Avviso di rettifica
Errata corrige
Errata corrige
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifica apportata ai sensi del DL.vo 29/12/2007, n. 274. Modifica apportata ai sensi del Regolamento (CE) n. 1234/2008 Titolare AIC: Valeas spa - Via Vallisneri, 10 - 20133 Milano Specialita' medicinale: FEVRALT - AIC N. 038712016/M Dosaggio, forma farmaceutica e confezioni: 100 mg/5 ml sospensione orale per bambini - flacone 100 ml Codice pratica: C1B/2012/1928 - IT/H/142/001/IB/004/G Grouping variations (IA/IAin/IB) IB - B.II.b.1 Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product e) Site where any manufacturing operation(s) take place, except batch release, batch control, primary and secondary packaging, for non-sterile medicinal products (Temmler Italia srl) IAin - B.II.b.1 Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product: Primary packaging site. b) Primary packaging site (Temmler Italia srl) IAin - B.II.b.1 Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product: Secondary packaging site. a) Secondary packaging site (Temmler Italia srl) IAin - B.II.b.2 Change to batch release arrangements and quality control testing of the finished product. b) Replacement or addition of a manufacturer responsible for batch release 2. Including batch control/testing (Temmler Italia srl) IA - B.II.b.2 Change to batch release arrangements and quality control testing of the finished product. a) Replacement or addition of a site where batch control/testing take place (Eurofins BIOLAB) IB - B.II.e.1 Change in immediate packaging of the finished product. a) Qualitative and quantitative composition - 2. Semi-solid and non-sterile liquid pharmaceutical forms I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza indicata in etichetta. Il legale rappresentante dott.. Virgilio Bernareggi T12ADD17751