COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Tobral» (18A01908)
Estratto determina CIP IP n. 132 del 21 febbraio 2018 E' autorizzata l'importazione parallela del medicinale TOBREX eye drops, solution 0,3% 1 fl × 5 ml plastic bottle with LDPE dropper applicator and polypropylene screw caps dalla Bulgaria con numero di autorizzazione 9600004 il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: GMM Farma s.r.l. con sede legale in via Lambretta n. 2 - 20090 Segrate (MI). Confezione: TOBRAL «0,3% collirio, soluzione» flacone 5 ml. Codice A.I.C.: 042846042 (in base 10) 18VKUU (in base 32). Forma farmaceutica: collirio soluzione. Composizione: 100 ml contengono: principio attivo: tobramicina 0,3 g;
eccipienti: tyloxapol, benzalconio cloruro, acido borico (E284), sodio solfato anidro (E514), sodio cloruro, acqua depurata. Aggiunta di acido solforico e/o idrossido di sodio per mantenere i livelli di acidita' (livelli di pH). Indicazioni terapeutiche: «Tobral» 0,3% collirio, soluzione e' indicato negli adulti e nei bambini da un anno di eta' in poi per il trattamento delle infezioni dell'occhio e degli annessi oculari, causate da batteri sensibili alla tobramicina: congiuntiviti catarrali acute, sub-acute e croniche;
blefariti;
cheratiti batteriche;
dacriocistiti;
profilassi pre-e post- operatoria negli interventi sul segmento anteriore. Officine di confezionamento secondario: De Salute...
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