SANDOZ S.P.A. -
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007 n.274 e del Regolamento (CE) 1234/2008 Titolare: Sandoz S.p.A. Medicinale: ETINILESTRADIOLO E DROSPIRENONE SANDOZ 0,02 mg/3 mg compresse rivestite con film Codice AIC: 041347/M -Confezioni: Tutte Procedura Europea n. NL/H/2347/001/IB/001 - Codice Pratica: C1B/2013/345 Modifica tipo IB n. A.2.b: modifica della denominazione del medicinale da "Etinilestradiolo e drospirenone Sandoz" a "Rubidelle" Medicinale: NEKOTOR 10 mg e 20 mg capsule gastroresistenti Codice AIC: 039902/M -Confezioni: Tutte Procedura Europea n. UK/H/4500/001-002/IB/002- Codice Pratica: C1B/2012/2412 Modifica tipo IB n. A.2.b: modifica della denominazione del medicinale da "Nekotor" a "Egapal" Medicinale: RILUZOLO SANDOZ 50 mg compresse rivestite con film Codice AIC: 041946/M -Confezioni: Tutte Procedura Europea n. NL/H/1934/01/IA/002- Codice Pratica: C1A/2012/2638 Modifica tipo IAin n. B.II.b.1.a): aggiunta di Pieffe Depositi S.r.l, Via Formellese Km 4,300, 00060 Formello (RM), Italia come sito di confezionamento secondario Medicinale: LEVETIRACETAM SANDOZ 250 mg, 500 mg e 1000 mg compresse rivestite con film Codice AIC: 040440/M - Confezioni: Tutte Procedura Europea n. NL/H/2151/001,002, 004/IA/001/G - Codice Pratica: C1A/2012/1978 Grouping of variations: tipo IA n.B.I.a.3.a): aumento della dimensione del lotto del principio attivo da 250 + 10 kg a 325 +20 kg + tipo IA n. B.II.b.4.a): aumento della dimensione del lotto del prodotto finito da 110.000 a 880.000 compresse rivestite con film. Medicinale: BETTAMOUSSE 1 mg/g (0,1%) schiuma cutanea Codice AIC: 034226/M -Confezioni: Tutte Procedura Europea n. UK/H/0240/IB/021/G - Codice Pratica: C1B/2012/2546 Grouping of variations: tipo IB n. B.II.b.1.a) + B.II.b.1.b) + B.II.b.1.e) B.II.b.4.b): aggiunta di del...
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