COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Tetravac» (11A08892)
Estratto determinazione V & A.PC/III/446 del 14 giugno 2011
Specialita' medicinale: TETRAVAC.
Confezioni:
A.I.C. n. 034127011/M - 1 siringa preriempita monodose sospensione 0,5 ml con ago;
A.I.C. n. 034127023/M - 10 siringhe preriempite monodose sospensione 0,5 ml con ago;
A.I.C. n. 034127035/M - 1 siringa preriempita monodose sospensione 0,5 ml senza ago;
A.I.C. n. 034127047/M - 10 siringhe preriempite monodose sospensione 0,5 ml senza ago;
A.I.C. n. 034127050/M - 10 siringhe preriempite con nuovo cappuccio copriago da 0,5 ml;
A.I.C. n. 034127062/M - 1 siringa preriempita con nuovo cappuccio copriago da 0,5 ml;
A.I.C. n. 034127074/M - 1 siringa preriempita monodose sospensione 0,5 ml senza ago con 1 ago separato;
A.I.C. n. 034127086/M - 1 siringa preriempita monodose sospensione 0,5 ml senza ago con 2 aghi separati;
A.I.C. n. 034127098/M - 10 siringhe preriempite monodose sospensione 0,5 ml senza ago con 10 aghi separati;
A.I.C. n. 034127100/M - 10 siringhe preriempite monodose sospensione 0,5 ml senza ago con 20 aghi separati;
Titolare AIC: Sanofi Pasteur MSD SNC.
Numero Procedura Mutuo Riconoscimento: SE/H/0154/001/II/048/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 principio attivo
Modifica nella procedura di prova del principio attivo o delle materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del...
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