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
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' Medicinale: PRIORIX TETRA Codice confezioni: 038200.../M in tutte le confezioni autorizzate Codice Pratica: C1B/2012/876 (Proc. Europea: DE/H/0468/001-002/IB/035) Tipologia variazione: Tipo IB B.I.a.3 Modifica della dimensione del lotto (comprese le classi di dimensione del lotto) del principio attivo o della sostanza intermedia: Aggiunta di una Unita' A del building WN27 per la produzione dei bulk di rosolia e varicella, in aggiunta alle unita' C e D gia' approvate. Specialita'...
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