COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vaqta» (20A03860)
Estratto determina AAM/PPA n. 381/2020 del 12 luglio 2020 Si autorizza il seguente grouping di variazioni, relativamente al medicinale VAQTA: tipo II, B.II.e.1b)2 - Modifica del confezionamento primario del prodotto finito. Modifica del tipo di contenitore o aggiunta di un nuovo contenitore. Medicinali sterili e medicinali biologici o immunologici. Introduzione di nuovi componenti della siringa come alternativa ai componenti della siringa attualmente autorizzati per le siringhe preriempite del vaccino epatite A, 50 U/1 ml e 25 U/0,5 ml (dosi adulte e pediatriche);
tipo IA, B.II.e.7b) - Modifica del fornitore di elementi o di dispositivi di confezionamento (quando sono menzionati nel fascicolo). Sostituzione o aggiunta di fornitore. Aggiunta di un sito, come fornitore alternativo dei materiali dei contenitori primari. Per effetto delle sopracitate variazioni, si modifica il riassunto delle caratteristiche del prodotto (RCP), paragrafi 4.4 e 6.5. Confezioni A.I.C. numeri: 033317013 - «50 U/1 ml sospensione iniettabile» 1 siringa preriempita con 1 ago presaldato;
033317025 - «25 U/0,5 ml sospensione iniettabile» 1 siringa preriempita con ago presaldato;
033317037 - «50 U/0,5 ml sospensione iniettabile» 1 siringa preriempita senza ago presaldato;
033317049 - «25 U/0,5 ml sospensione iniettabile» 1 siringa preriempita senza ago presaldato;
033317052 - «25 U/0,5 ml sospensione iniettabile» 1 siringa preriempita con 1 ago separato;
033317064 - «25 U/0,5 ml sospensione iniettabile» 1 siringa preriempita con 2 aghi separati;
033317076 - «50 U/1 ml...
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