Actavis Group Ptc ehf Rappresentante per l'italia: Actavis Italy S.p.A.
Modifica secondaria di autorizzazione all'immissione in commercio di medicinali per uso umano. Modifica apportata ai sensi del D.Lgs 29 dicembre 2007, n.274.
Titolare: ACTAVIS Group PTC ehf - Reykjavi'kurvegi 76-78, 220
Hafnarfjorður (Islanda) Medicinale: RISPERIDONE ACTAVIS Confezioni e numeri A.I.C.: per tutti i dosaggi e le confezioni autorizzate - AIC n. 037875/M.
Procedura n. SE/H/0681/003-006/IB/001
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Variazione di tipo IB n. 2: Modifica del nome del prodotto medicinale in Svezia da: Risperidone Medis a: Risperidon Actavis e in Spagna da:
Risperidone Medis a: Risperidona Actavis 1mg/2mg/3mg/4mg comprimidos recubiertos con peli'cula EFG.
Medicinale: RISPERIDONE ACTAVIS Confezioni e numeri A.I.C.: per tutti i dosaggi e le confezioni autorizzate - AIC n. 037875/M.
Procedura n. SE/H/0681/003-006/IA/002
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Variazione di tipo IA n. 7b1 e conseg. 7a, 8b2: Aggiunta di un sito di confezionamento primario e secondario, controllo e rilascio lotti del prodotto finito Actavis Ltd. - BT 16 Bulebel Industrial Estate Zeitun - Malta.
Medicinale: RISPERIDONE ACTAVIS Confezioni e numeri A.I.C.: per tutti i dosaggi e le confezioni autorizzate - AIC n. 037875/M.
Procedura n. SE/H/0681/003-006/IA/003
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Variazione di tipo IA n. 15a: Presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato relativo ad un principio attivo da parte di un produttore attualmente approvato: R0 CEP 2002 - 151 REV 02
Medicinale: RISPERIDONE ACTAVIS Confezioni e numeri A.I.C.: per tutti i dosaggi e le confezioni...
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