COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Engerix B». (13A07200)
Estratto determinazione V &
A/1308 del 23 luglio 2013 Specialita' Medicinale: ENGERIX B Confezioni: 026653016/M - 1 flac. monodose + siringa 026653028/M - 1 flac. monodose 026653030/M - 10 flac. monodose + siringhe 026653042/M - 25 flac. monodose + siringhe 026653055/M - bb 1 flac. 10 mcg + siringa 026653067/M - bb 25 flac.10 mcg + 25 siringhe 026653079/M - siringa preriempita sosp iniett 1ml/20mcg 026653081/M - 10 siringhe preriempite sosp iniett 1ml/20mcg 026653093/M - siringa preriempita sosp iniett 0,5ml/10mcg 026653105/M - 10 siringhe preriempite sosp iniett 0,5ml/10mcg Titolare AIC: Glaxosmithkline Biologicals S.A. N° Procedura Mutuo Riconoscimento: BE/H/0009/001-002/II/052 Tipo di Modifica: B.I.c.1.b Modifiche nel confezionamento primario del principio attivo Composizione qualitativa e/o...
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