A.C.R.A.F. S.P.A. AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO
Modifica Secondaria di un'Autorizzazione all'Immissione
In Commercio di Specialita' Medicinale per Uso Umano
Titolare: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A. - Viale Amelia n. 70 - 00181 Roma
Specialita' Medicinale: MOMENDOL 220 mg compresse rivestite con film
Confezioni e Numeri di AIC:
12 compresse (AIC n. 025829084) e 24 compresse (025829185)
Comunicazione Agenzia Italiana del Farmaco del 15-01-2008. Codice Pratica: N1B/07/2185
Modifiche apportate ai sensi del Regolamento (CE) 1084/2003:
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a Sostituzione o aggiunta di un sito di produzione per imballaggio secondario per tutti i tipi di forme farmaceutiche
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b.1 Sostituzione o aggiunta di un sito di produzione per imballaggio primario di forme farmaceutiche solide, ad es. compresse e capsule
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c Sostituzione o aggiunta di un sito di produzione per tutte le altre operazioni produttive ad eccezione del rilascio dei lotti
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b.2 Sostituzione o aggiunta di un produttore responsabile del rilascio dei lotti (incluso in...
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