Autorizzazione all'immissione in commercio della specialita' - medicinale per uso umano "Articaina con Adrenalina Denit"
Decreto A.I.C. n. 142 del 16 aprile 1998
Specialita' medicinale: ARTICAINA CON ADRENALINA DENIT nella forma e confezioni: "Articaina 4% con adrenalina 1:100.000" 100 tubofiale soluzione iniettabile 1,8 ml e "Articaina 4% con adrenalina 1:200.000" 100 tubofiale soluzione iniettabile 1,8 ml".
Titolare A.I.C.: Denit S.r.l, con sede legale e domicilio fiscale in Milano, via Melchiorre Gioia n. 168 - codice fiscale 06308260154.
Produttore: la produzione, il controllo ed il confezionamento della specialita' medicinale sopra indicata sono effettuati dalla Societa' Laboratorios Inibsa S.A., nello stabilimento sito in Llissa de Vall (Barcellona-Spagna), Carret. Sabadell a Granollers km 14,5.
Confezioni autorizzate: numeri A.I.C. e classificazione ai sensi dell'art. 8, comma 10 della legge n. 537/1993: "Articaina 4% con adrenalina 1:100.000": 100 tubofiale soluzione iniettabile 1,8 ml; A.I.C.: n. 031530013 (in base 10), 0Y270X (in base 32); Classe: "C"; "Articaina 4% con adrenalina 1:200.000": 100 tubofiale soluzione iniettabile 1,8 ml; A.I.C.: n. 031530025 (in base 10), 0Y2719 (in base 32); Classe: "C".
Composizione: "Articaina 4% con adrenalina 1:100.000": ogni ml di soluzione contiene: principi attivi: articaina cloridrato 40,00 mg; adrenalina bitartrato 18,20 mcg equivalenti a mcg 10 di adrenalina; eccipienti: sodio cloruro, sodio metabisolfito, acqua per preparazioni iniettabili (nelle quantita' indicate nella documentazione di tecnica farmaceutica acquisita agli atti); "Articaina 4% con adrenalina 1:200.000": ogni ml di soluzione contiene: principi attivi: articaina cloridrato 40,00; adrenalina...
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