Polifarma S.p.A.
Modifica secondaria 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: POLIFARMA S.p.A. - Viale dell'Arte, 69 - 00144 Roma
SPECIALITA' MEDICINALE: AMLOPOL CONFEZIONE E NUMERI AIC: '5 mg compresse', 28 compresse AIC n.
038075014 - '10 mg compresse', 14 compresse AIC n. 038075026
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE ) n. 1084/2003: N.
7.a)- Sostituzione di sito di produzione responsabile del confezionamento secondario per tutti i tipi di forme farmaceutiche:
APPOSIZIONE BOLLINO OTTICO: DEPO PACK S.n.c. di DEL DEO SILVIO & C.
VIA MORANDI, 28 - 21047 SARONNO (VA) .
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE ) n. 1084/2003: N.
7.a)- Aggiunta di sito di produzione responsabile del confezionamento secondario per tutti i tipi di forme farmaceutiche: APPOSIZIONE BOLLINO OTTICO: LINEA FRESCO S.p.A. VIA CAMPOBELLO 1-00040 - POMEZIA (RM) .
SPECIALITA' MEDICINALE: CENTRUM CONFEZIONE E NUMERI AIC: '150 mg +150 mg IM IV 5 fiale polvere + 5 fiale solventi 5 ml' AIC n. 021539061
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE ) n. 1084/2003: N.
9- Eliminazione di un sito di produzione responsabile della fase di:
'PRODUZIONE E CONTROLLO QUALITA'': I.S.F. S.p.A. VIA TIBURTINA KM 10,400 ROMA.
SPECIALITA' MEDICINALE: CENTRUM CONFEZIONE E NUMERI AIC: '100 mg +100 mg compresse' 20 compresse AIC n. 021539046
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE ) n. 1084/2003: N.
9-...
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