Dorom S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007 n. 274.
Medicinale: Acido Ursodesossicolico Dorom Codice A.I.C.: 034317038 - '450 mg capsule a rilascio modificato' 20 capsule a rilascio modificato Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Codice Pratica N1B/09/1198
1) Tipo IB.42.b: Modifica delle condizioni di conservazione del prodotto finito (da 'A temperatura ambiente secondo FU' a 'Conservare a temperatura inferiore ai 30°C').
Codice Pratica N1B/09/1183
2) Tipo IB.7.c e conseguenti IA.7.b.1 e IA.7.a e IA.8.b.2:
Sostituzione di un sito di produzione per tutto il processo produttivo del prodotto finito, inclusi il confezionamento primario e secondario e sostituzione di un produttore responsabile del rilascio dei lotti, incluso il controllo dei lotti (da'Consorzio Farmaceutico e Biotecnologico Bioprogress S.r.l. - Anagni (FR)' a 'ABC Farmaceutici S.p.A. - Ivrea (TO) Medicinale: Tramadolo Dorom Codice A.I.C.: 033981085 - '100 mg/2 ml soluzione iniettabile' 5 fiale e 033981097 '100 mg/2 ml soluzione iniettabile' 10 fiale Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Codice Pratica: N1A/09/2042
Tipo IA.9: Eliminazione di un sito di produzione del prodotto finito (Jenahexal Pharma GmbH - Germania).
Medicinale: Tramadolo Dorom Codice A.I.C.: 033981 - in tutte le confezioni autorizzate Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Codice Pratica: N1A/09/2043
Tipo IA.9: Eliminazione di un sito di produzione del prodotto finito (Heumann PCS GmbH - Germania).
Medicinale: Lattulosio Dorom Codice A.I.C.: 033239017 - '66,7% sciroppo' - flacone 200 ml Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Codice Pratica N1A/09/1743
Tipo IA.9: Eliminazione di un sito di produzione del prodotto finito (Doppel Farmaceutici...
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