BOEHRINGER INGELHEIM ITALIA S.p.A.
MODIFICHE SECONDARIE DI AUTORIZZAZIONI ALL'IMMISSIONE IN COMMERCIO DI
SPECIALITA' MEDICINALI PER USO UMANO
TITOLARE: Boehringer Ingelheim Italia s.p.a., Sede Legale Reggello (Firenze) - Loc. Prulli 103/c.
COMUNICAZIONI AGENZIA ITALIANA DEL FARMACO
SPECIALITA' MEDICINALE: CATAPRESAN
CONFEZIONI E NUMERI A.I.C.:
"300 mcg compresse" 30 compresse - AIC n° 021502024
COMUNICAZIONI AGENZIA ITALIANA DEL FARMACO AIFA.AIC/113180 DEL 08 NOVEMBRE 2007. CODICE PRATICA: N1B/07/1746
MODIFICA APPORTATA AI SENSI del Regolamento (CE) 1084/2003: 37.b e 38.c Aggiunta di un nuovo parametro di prova alle specifiche del prodotto finito "Impurezze e prodotti di degradazione del principio attivo" e conseguente introduzione del relativo metodo di determinazione HPLC.
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