COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Edeven C.M.»
Estratto determinazione A.I.C./N n. 2976 del 21 dicembre 2007
Descrizione del medicinale e attribuzione numero A.I.C.: e' autorizzata l'immissione in commercio del medicinale: ´EDEVEN C.M.ª, nelle forme e confezioni: ´1% + 5% gelª 1 tubo da 40 g e ´2% + 5% gelª 1 tubo da 40 g, alle condizioni e con le specificazioni di seguito indicate.
Titolare A.I.C.: Istituto Biochimico Italiano Giovanni Lorenzini S.p.A con sede legale e domicilio fiscale in Aprilia (Latina), via Fossignano n. 2, cap. 04011, codice fiscale n. 02578030153.
Confezione:
´1% + 5% gelª 1 tubo da 40 g;
A.I.C. n. 037028014 (in base 10) 13B05G (in base 32).
Forma farmaceutica: gel.
Validita' prodotto integro: 2 anni dalla data di fabbricazione.
Produttore e responsabile del rilascio dei lotti: Istituto Biochimico Italiano Giovanni Lorenzini S.p.a. stabilimento sito in Aprilia (Latina), via Fossignano n. 2 (tutte le fasi).
Composizione: 100 g di gel contengono:
principio attivo: Escina 1g; Dietilamina salicilato 5 g;
eccipienti: Carbossipolimetilene 2 g; Meglumina 3 g; Glicol propilenico 0,5 g; Alcool etilico 18,6 g; Sodio edetato 0,01 g; Esildecanolo e Esildecil laurato 5 g; Etossidiglicol 2 g; Butilidrossitoluolo 0,1 g; Titanio diossido 0,1 g; Essenza lavanda 0,292 g; Essenza nerolene 0,132 g; Acqua depurata q.b. a 100 g.
Confezione:
´2% + 5% gelª 1 tubo da 40 g;
A.I.C. n. 037028026 (in base 10) 13B05U (in base 32).
Forma farmaceutica: Gel.
Validita' prodotto integro: 2 anni dalla data di fabbricazione.
Produttore e responsabile del rilascio dei lotti: Istituto Biochimico Italiano Giovanni Lorenzini S.p.a. stabilimento sito in Aprilia (Latina), via Fossignano n. 2 (tutte le fasi).
Composizione: 100 g di gel contengono:
principio attivo: Escina 2 g; Dietilamina salicilato 5 g;
eccipienti: Carbossipolimetilene 2 g; Meglumina...
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