Avviso di rettifica
Errata corrige
Errata corrige
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Titolare: Abbott S.r.l., S.R. 148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT) Medicinale: FEMOSTON Confezioni e numeri di A.I.C.: L 1/10 mg compresse rivestite con film - astuccio da 28 cpr - AIC 033639055/M L 1/10 mg compresse rivestite con film - astuccio da 3 cicli da 28 cpr - AIC 033639067/M Modifica apportata ai sensi del Regolamento (CE) n. 1234/2008: Codice Pratica: C1B/2012/1852 - MRP n. NL/H/0124/003/IB/034/G conclusasi a livello europeo il 5 settembre 2012 - Grouping di: Variazioni relative alle compresse film rivestite da 1 mg di Estradiolo: - 2 Variazioni tipo IB n. B.II.d.2.d - Change in test procedure for the finished product - Other changes to a test procedure (including replacement or addition) - Change in the analytical methods: Identity, assay, purity; Dissolution. - 1 Variazione tipo IB Art. 5 n. B.II.d.1.z - Change in the specification parameters and/or limits of the finished product - Other variation - Change in the analytical methods: Uniformity testing - 1 Variazione tipo IA n. B.II.d.1.c - Change in the specification parameters and/or limits of the finished product - Addition of a new specification parameter to the specification with its corresponding test method - Change in the specifications: Introduction of second identity test by UV. - 4 Variazioni tipo IB n. B.II.d.1.z - Change in the specification parameters and/or limits of the finished product - Other variation - Deletion of the disintegration test; Change in the specification of the impurities - Update of impurities related to Estradiol; Change in test frequency for the identity test of titanium dioxide; Change in test frequency for the microbiological testing. Variazioni relative alle compresse film rivestite da 1 mg di Estradiolo e 10 mg di Didrogesterone: - 2 Variazioni tipo IB n. B.II.d.2.d - Change in test procedure for the finished product - Other changes to a test procedure (including replacement or addition) - Change in the analytical methods: Identity, assay, purity; Dissolution. - 1 Variazione tipo IB Art. 5 n. B.II.d.1.z - Change in the specification parameters and/or limits of the finished product - Other variation - Change in the analytical methods: Uniformity testing - 1 Variazione tipo IA n. B.II.d.1.c - Change in the specification parameters and/or limits of the finished product - Addition of a new specification parameter to the specification with its corresponding test method - Change in the specifications: Introduction of second identity test by UV. - 4 Variazioni tipo IB n. B.II.d.1.z - Change in the specification parameters and/or limits of the finished product - Other variation - Deletion of the disintegration test; Change in the specification of the impurities - Update of impurities related to Estradiol; Change in test frequency for the identity test of the colour additive; Change in test frequency for the microbiological testing. I lotti gia' prodotti sono mantenuti in commercio fino alla data di scadenza indicata in etichetta. Un procuratore dott.ssa Maria Antonietta Compagnone T12ADD15060