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 Comunicazione Agenzia Italiana del Farmaco del 23/10/2008. CODICE PRATICA: N1B/08/1354
MEDICINALE: VERSUS CONFEZIONI E NUMERI DI A.I.C.:
'3% Crema' tubo 50 g - AIC N° 021179054 '3% Unguento' tubo 50 g - AIC N° 021179104 '1% Pasta cutanea' tubo 50 g - AIC N° 021179128
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: 37.b.
Aggiunta di un nuovo parametro di prova alle specifiche del prodotto finito.
Comunicazione Agenzia Italiana del Farmaco del 29/10/2008. CODICE PRATICA: N1A/08/2171
MEDICINALE: TACHICAF CONFEZIONI E NUMERI DI A.I.C.:
'1000 mg + 130 mg granulato effervescente per soluzione orale' 10 bustine - AIC N° 036120018 '1000 mg + 130 mg granulato effervescente per soluzione orale' 12 bustine - AIC N° 036120020 '1000 mg + 130 mg granulato effervescente per soluzione orale' 16 bustine - AIC N° 036120032 '1000 mg + 130 mg granulato effervescente per soluzione orale' 20 bustine - AIC N° 036120044
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: 15.a presentazione di un certificato d'idoneita' della farmacopea europea nuovo o aggiornato da parte di un produttore attualmente approvato.
Comunicazione Agenzia Italiana del Farmaco del 29/10/2008. CODICE PRATICA: N1A/08/2015
MEDICINALE: UNITRAMARIM CONFEZIONI E NUMERI DI A.I.C.:
'100 mg/ml gocce orali, soluzione' flacone 120 ml - AIC N°
032102030 '100 mg/2 ml soluzione iniettabile' 5 fiale 2 ml - AIC N°
032102042
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: 8.b.1
Sostituzione dell'officina di produzione 'Edmond Pharma, Via dei Giovi 131, 20037 Paderno Dugnano (Mi)' con 'Pierrel S.p.A., Strada Statale Appia 46/48, 81043 Capua (Ce)' per la fase di rilascio dei lotti di prodotto finito.
Comunicazione Agenzia Italiana del Farmaco del 30/10/2008. CODICE...
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