Angenerico S.p.A.
MODIFICA SECONDARIA DI UN'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO DI SPECIALITA' MEDICINALE PER USO UMANO. Modifica apportata ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274.
TITOLARE: Angenerico SpA Via Nocera Umbra, 75 - 00181 Roma MEDICINALE: SIMVASTATINA ANGENERICO CONFEZIONI E NUMERI DI A.I.C.: tutte NUMERO DI PROCEDURA: DE/H/2046/001-007/IA/007
Modifica apportata ai sensi del Regolamento (CE) 1084/2003:
Tipo IA15a - 'Presentazione di un certificato d'idoneita' della farmacopea europea aggiornato relativo ad un principio attivo da parte di API Zhejiang Hisun R1-CEP 2002-172-Rev 01' TITOLARE: Angenerico SpA Via Nocera Umbra, 75 - 00181 Roma MEDICINALE: FUROSEMIDE ANGENERICO CONFEZIONI E NUMERI DI A.I.C.:
20 compresse da 500 mg AIC n. 035979018.
Modifica apportata ai sensi del Regolamento (CE) 1084/2003:
Tipo IA15A - 'Presentazione del certificato di conformita' alla Farmacopea Europea per produttore principio attivo gia' autorizzato (FIS- Fabbrica Italiana Sintetici S.P.A.) R0-CEP 2004-005-REV 02' TITOLARE: Angenerico SpA Via Nocera Umbra, 75 - 00181 Roma MEDICINALE: CEFTRIAXONE ANGENERICO CONFEZIONI E NUMERI DI A.I.C.:
1 g/3.5 ml polvere e solvente per soluzione iniettabile per uso intramuscolare, 1 flacone polvere + 1 fiala solvente 3.5 ml AIC N° 036095014
Modifica apportata ai sensi del Regolamento (CE) 1084/2003:
Tipo IA21a - Presentazione del certificato di conformita' alla Farmacopea Europea aggiornato relativo ad un eccipiente (Lidocaina) da parte di un produttore attualmente approvato TITOLARE: Angenerico SpA Via Nocera Umbra, 75 - 00181 Roma MEDICINALE: ACIDO URSODESOSSICOLICO ANGENERICO CONFEZIONI E NUMERI DI...
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