SIRTON MEDICARE S.p.A.
COMUNICATO MODIFICA SECONDARIA DI UNA AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO DI SPECIALITA' MEDICINALE PER USO UMANO Comunicazione Agenzia Italiana del Farmaco - Codice Pratica: N1A/08/729 del 15 maggio 2008
TITOLARE: SIRTON MEDICARE S.p.A. - P.zza XX Settembre 2 - VILLA GUARDIA (CO)
SPECIALITA' MEDICINALE: NARCAN
CONFEZIONI E NUMERI A.I.C.:
"0,4 mg soluzione iniettabile" 1 fiala da 1 ml - A.I.C .n. 023976018
"0,04 mg soluzione iniettabile" 1 fiala da 2 ml - AIC n. 023976020
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: : n. 15.A: Presentazione di un certificato d'idoneita' alla Farmacopea Europea aggiornato (R1-CEP 1966-074-Rev.02) relativo al produttore del principio attivo - sito di produzione di Apeldorn, Netherlands.
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