HEXAL 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: Hexal S.p.A. Medicinale: CITALOPRAM HEXAL 20 e 40 mg compresse rivestite con film. Confezioni: Tutte - Codice AIC Medicinale: 036367/M Procedura Europea n. NL/H/0366/001;003/IA/049/G Codice Pratica: C1A/2013/360 Grouping variation: n. 2 x tipo IA n. B.III.1.a.2 - Aggiornamento CEP per il principio attivo da parte dei produttori gia' autorizzati Zhejiang Huahai Pharmaceutical Co. Ltd da R0-CEP 2010-037 Rev 00 a R0-CEP 2010-037 Rev 01 e Mylan Laboratories Limited da R0-CEP 2009-016 Rev 02 a R0-CEP 2009-016 Rev 03. Medicinale: TORASEMIDE HEXAL 10 mg compresse Confezioni: Tutte - Codice AIC Medicinale: 036487/M Procedura Europea n. SE/H/0361/003/IB/036/G Codice Pratica: C1B/2013/511 Grouping variation: Modifica Tipo IBun n. B.II.f.z - Aggiornamento dei dati di stabilita' del prodotto finito + Tipo IA n. A.7 - Eliminazione del sito di produzione del principio attivo Sanochemia Pharmazeutika AG. Medicinale: CLARITROMICINA HEXAL 250 mg e 500 mg compresse rivestite con film. Confezioni: Tutte - Codice AIC Medicinale: 037833/M Procedura Europea n. NL/H/1649/001-002/IA/032/G Codice Pratica: C1A/2013/585 Grouping variation: Modifica Tipo IAin n. B.II.b.1.b + IAin n. B.II.b.1.a + IAin n. B.II.b.2.b.2 - Aggiunta sito per il confezionamento primario, secondario, controllo e rilascio lotti: S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania. Medicinale...
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