Autorizzazione all'immissione in commercio della specialita' medicinale
Estratto determinazione A.I.C./N n. 568 del 9 maggio 2006
Descrizione del medicinale e attribuzione n. A.I.C.
E' autorizzata l'immissione in commercio del medicinale: KESTINE anche nella forma e confezione: ´1 mg/ml sciroppoª flacone 120 ml con dosatore siringa 5 ml.
Titolare A.I.C.: Almirall S.p.a. con sede legale e domicilio fiscale in via Vespucci, 2, 20124 Milano, Italia, codice fiscale 06037901003.
Confezione: ´1 mg/ml sciroppoª flacone 120 ml con dosatore siringa 5 ml - A.I.C. 034930115 (in base 10), 119ZG3 (in base 32).
Forma farmaceutica: sciroppo.
Validita' prodotto integro: 2 anni dalla data di fabbricazione.
Produttore e responsabile del rilascio dei lotti: Industrias Farmaceuticas Almirall Prodesfarma S.L. - 08740 Sant Andreu De La Barca, Barcellona (Spagna), Carreteras Nacional II, km 593 (tutte le fasi).
Composizione: 1 ml di sciroppo contiene:
principio attivo: ebastina 1 mg;
eccipienti: acido lattico (E 270) 6,6 mg; olio di ricino poliossidrilato idrogenato 10 mg; neoespiridina diidrocalcone (E 959) 1,06 mg; anetolo 0,25 mg; sodiometil p-idrossibenzoato (E 219) 1,2 mg; sodio propil p-idoprssibenzoato (E 217) 0,3 mg; glicerolo (E 422) 200 mg; sorbitolo liquido (E 420) 100 mg; acqua depurata quanto basta a 1 ml.
Indicazioni terapeutiche: ebastina e' indicata nel trattamento sintomatico di riniti allergiche (stagionali o perenni) associate o meno a congiuntiviti...
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