Eg. 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
Titolare: EG. S.p.A Specialita' Medicinale: OMEPRAZOLO EG Numeri A.I.C. e Confezioni : 034866 - In tutte le confezioni.
Procedura europea n° DE/H/0244/001-003/IB/049
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IB n. 2: Mod. nome del prodotto medicinale in FI: da Omeprazol STADA a Gastrostad.
Specialita' Medicinale: PAROXETINA EG Numeri A.I.C. e Confezioni : 035700 - In tutte le confezioni.
1) Procedura europea n° SE/H/0285/001/IB/039
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IB n. 38c: Modifica di una procedura di prova del prodotto finito (Dissolution).
2) Procedura europea n° SE/H/0285/001/IB/040
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IB n. 38c: Sostituzione di una procedura di prova del p.f.: da uniformita' di massa a uniformita' delle unita' di dosaggio.
Specialita' Medicinale: AMOXICILLINA+ACIDO CLAVULANICO EG Numeri A.I.C. e Confezioni : 036820 - In tutte le confezioni.
Procedura europea n° DE/H/2057/001/IA/001
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IA n. 15b2:
Presentazione CEP aggiornato da parte di nuovo produttore: CKD Bio Corporation - CEP n. R0-CEP 2003-183-Rev 02.
Specialita' Medicinale: GLIMEPIRIDE EG Numeri A.I.C. e Confezioni : 036962 - In tutte le confezioni.
Procedura europea n° DK/H/0864/002/IB/011
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IB n. 7c: Aggiunta sito di produzione del prodotto finito per tutte le operazioni produttive ad eccezione del rilascio dei lotti: Zdravlje AD Leskovac.
Specialita' Medicinale: PRAVASTATINA EG Numeri A.I.C. e Confezioni : 037682 - In tutte le confezioni.
Procedura europea n° NL/H/0961/002-003/IA/007
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Tipo IA n. 25b1:
Modifica del p.a. per essere in conformita' all'aggiornamento della EP ed. cor..
Specialita' Medicinale...
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