ROTTAPHARM S.p.A.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano Comunicazioni Agenzia Italiana
del Farmaco del 14 Gennaio 2008.
TITOLARE: ROTTAPHARM S.p.A. - Galleria Unione, 5 - 20122 Milano
SPECIALITA' MEDICINALE: AFTAB
CONFEZIONI E NUMERI A.I.C.:
"25 mcg compresse" 10 compresse A.I.C. 028478016
"6 compresse buccali mucoadesive 0,025 mg" (sospesa) A.I.C. 028478030
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003:
Pratica N/1A/07/2147
Variazione IA.5: sostituzione dalla sede legale con l'indirizzo della sede dello stabilimento dell'officina responsabile della produzione e del confezionamento primario:
da: TEIJIN PHARMA LTD, con stabilimento sito in 1-1 Uchisaiwai-cho 2 Chome, Chiyoda-ku (Tokio)
a: TEIJIN PHARMA LTD, con stabilimento sito in 2-1 Hinodecho, Iwakuni-shi, Yamaguchi (Giappone)
SPECIALITA' MEDICINALE: DOROXAN
CONFEZIONI E NUMERI A.I.C.:
"1% schiuma cutanea" 1 contenitore sotto pressione A.I.C. 034758021
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003:
Pratica N/1A/07/2353
Variazione IA.4: modifica della ragione sociale dell'officina di produzione del principio attivo del medicinale (Diclofenac Sodico):
...
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