GLAXOSMITHKLINE S.P.A. -
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del D.L.vo 29/12/2007 n.274 e del Regolamento (CE) n. 1234/2008 Titolare: GlaxoSmithKline S.p.A.- Via A. Fleming, 2- Verona Specialita' Medicinali: -ADARTREL - Confezioni e n. AIC: 037229.../M, in tutte le confezioni autorizzate -COMBODART - Confezioni e n. AIC: 039913.../M in tutte le confezioni autorizzate Titolare: STIEFEL LABORATORIES (IRELAND) Ltd Rappresentante legale e di vendita GlaxoSmithKline S.p.A.-Via A. Fleming, 2- Verona Specialita' Medicinali: -DUAC - Confezioni e n. AIC: 036925.../M in tutte le confezioni autorizzate -SEBIPROX - Confezioni e n. AIC: 035446.../M in tutte le confezioni autorizzate Codice Pratica: C1A/2013/367 (Proc. Europea: FR/H/xxxx/IA/41/G) Tipologia Variazione: Grouping Tipo IAIN A.1 Modifiche del nome e/o dell'indirizzo del titolare dell'autorizzazione all'immissione in commercio (Cambio indirizzo nello Stato Membro: Cecoslovacchia). Titolare: GlaxoSmithKline S.p.A.- Via A. Fleming, 2- Verona Specialita' Medicinale: COMBODART Confezioni e n. AIC: 039913.../M in tutte le confezioni autorizzate Specialita' Medicinale: DUTASTERIDE-TAMSULOSINA CLORIDRATO GLAXOSMITHKLINE Confezioni e n. AIC: 039906.../M in tutte le confezioni autorizzate Codice Pratica:C1A/2013/362 (Proc. Europea: DE/H/xxxx/IA/0286/G) Tipologia Variazione: Grouping Tipo IAIN B.III.1.a.3 Presentazione di un certificato di conformita' alla farmacopea europea nuovo o aggiornato (per una sostanza attiva). Nuovo certificato presentato da un nuovo fabbricante (sostituzione o aggiunta). In aggiunta rimozione del sito di produzione: Synthon Praga con conseguente aggiornamento del CEP: R0-CEP 2010-204 Rev 01...
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