Avviso di rettifica
Errata corrige
Errata corrige
Modifica secondaria di un'A.I.C. di medicinale per uso umano, apportata ai sensi del D.L. 29 dicembre 2007, n. 274. Titolare A.I.C.: Janssen-Cilag S.p.a. Modifica apportata ai sensi del Regolamento CE n. 1234/2008. Ai sensi della determinazione AIFA 18 dicembre 2009, si informa dell'avvenuta approvazione delle seguenti variazioni. Medicinale: TOPAMX 25-50-100-200 mg compresse rivestite con film. Confezioni e numeri di A.I.C.: 60 compresse - A.I.C. n. 032023. C1A/2010/4716 - MRP SE/H/110/1-4/IA/48 - B.II.d.1.d) Deletion of a non significant specification parameter of the finished product: (Identification of iron oxide). C1B/2010/2495 - MRP SE/H/110/1-4/IB/49/G - B.II.b.1.a)-b)-e) Addition of a manufacturing site for all of the manufacturing process of the finished product & B.II.b.2.b).2 addition of a manufacturer responsible for patch release, including batch control/testing: (Janssen-Cilag S.p.a., Borgo S. Michele, Latina). Medicinale: TOPAMX 15-25 mg capsule rigide. Confezioni e numeri di A.I.C.: 60 capsule - A.I.C. n. 032023. C1A/2010/4719 - MRP SE/H/110/7-8/IA/51/G: B.II.c.4.a) Minor change in the synthesis of a non-pharmacopoeial excipient (hard gelatin capsules); A.5.b) Change in the name of a manufacturer (da: Cardinal Health PTS, LLC - a: Catalent Pharma solutions, LLC); A.7 Deletion of a manufacturing site (Cilag AG Switzerland as QC testing); B.II.b.1.a)-b) Replacement of a manufacturing site for part of the manufacturing process of the finished product & B.II.b.2.b).2 replacement of a manufacturer responsible for patch release, including batch control/testing: (Janssen-Cilag S.p.a., Borgo S. Michele, Latina); B.III.1.b.2-3 Submission of a new or updated Ph.Eur. TSE certificate of suitability for an excipient (gelatins). C1B/2010/2499 - MRP SE/H/110/7-8/IB/52/G: B.II.d.2 Change in test procedure for finished product - b): Replacement of: - HPLC methods for identification and assay of active substance and degradation compounds and for content uniformity testing - CE method for the assay of the inorganic degradation products; - d) Deletion of the alternative IC method for the assay of the inorganic degradation products; B.II.d.1.a Change in the specification limits of the finished product (tightening of limits for: organic degradation product RWJ-34826-000 and inorganic degradation product sulfamate). I lotti gia' prodotti alla data di pubblicazione nella Gazzetta Ufficiale possono essere mantenuti in commercio fino alla data di scadenza indicata in etichetta. Un procuratore: dott.ssa Eleonora Roselli TC10ADD7640