COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Typhim VI» (11A13466)
Estratto determinazione V & A/N/V n. 1196 del 4 ottobre 2011
Medicinale: TYPHIM VI.
Titolare A.I.C.: Sanofi Pasteur MSD Snc con sede legale e domicilio in 8, Rue Jonas Salk, 69367 - Lyon Cedex 07 (Francia).
Variazione A.I.C.: B.II.e.1.a.3 Modifica dell'imballaggio primario del prodotto finito. Composizione qualitativa e quantitativa medicinali sterili e medicinali biologici o immunologici.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata.
E' autorizzata la modifica relativa all'uso alternativo di nuovi pistoni:
da: elastomero (clorobromobutile);
a: elastomero (clorobromobutile, bromobutile, clorobutile).
La variazione modifica i paragrafi 3.2.P.1, 3.2.P.2.4, 3.2.P.5.4, 3.2.P.7, 3.2.P.8.1, 3.2.P.8.3 del modulo 3 di CTD.
Modifica degli stampati alla sezione 6.5 di RCP:
da: astuccio contenente una siringa preriempita da 0.5 ml (in vetro tipo I) con ago presaldato;
a: 0.5 ml di sospensione in siringa preriempita (vetro di tipo I) con guarnizione del pistone (elastomero clorobromobutilico, bromo butilico o clorobutilico) con ago presaldato e cappuccio copriago (elastomero poliisopropenico);
da: astuccio contenente una siringa preriempita da 0.5 ml ( in vetro tipo I) con 2 aghi separati nel blister;
a: 0.5 ml di sospensione in...
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