COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Pentavac» (11A08894)
Estratto determinazione V & A.PC/II/448 del 14 giugno 2011
Specialita' medicinale: PENTAVAC.
Confezioni:
A.I.C. n. 034126019/M - 1 flacone monodose polv. lio. + 1 siringa preriempita monodose senza ago sosp. iniettabile 0,5 ml;
A.I.C. n. 034126021/M - 10 flaconi monodose polv. lio. + 10 siringhe preriempite monodose senza ago sosp. iniettabile 0,5 ml;
A.I.C. n. 034126033/M - 1 flacone monodose polv. lio. + 1 siringa preriempita monodose con ago sosp. iniettabile 0,5 ml;
A.I.C. n. 034126045/M - 10 flaconi monodose polv. lio. + 10 siringhe preriempite monodose con ago sosp.iniettabile 0,5 ml;
A.I.C. n. 034126058/M - 1 flaconcino di polvere + 1 siringha preriempita con nuovo cappuccio copriago da 0,5 ml;
A.I.C. n. 034126060/M - 10 flaconcini di polvere + 10 siringhe preriempite con nuovo cappuccio copriago da 0,5 ml;
A.I.C. n. 034126072/M - «0,5 ml polvere e sospensione iniettabile» 1 flaconcino monodose + 1siringa pre-riempita monodose con 1 ago separato
A.I.C. n. 034126084/M - «0,5 ml polvere e sospensione iniettabile» 1 flaconcino monodose + 1siringa pre-riempita monodose con 2 aghi separati
A.I.C. n. 034126096/M - «0,5 ml polvere e sospensione iniettabile» 10 flaconcini monodose + 10 siringhe pre-riempite monodose con 10 aghi separati
A.I.C. n. 034126108/M - «0,5 ml polvere e sospensione iniettabile» 10 flaconcini monodose + 10 siringhe pre-riempite monodose con 20 aghi separati
Titolare AIC: Sanofi Pasteur MSD SNC.
Numero procedura mutuo riconoscimento: SE/H/0153/001/II/061/G.
Tipo di Modifica: Modifica dei parametri di specifica e/o dei limiti del principio attivo, di una materia prima, di una sostanza intermedia o di un reattivo utilizzato nel procedimento di fabbricazione del...
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