COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Yellox» (19A04367)
Estratto determina IP n. 419 dell'11 giugno 2019 Al medicinale YELLOX «0.9 mg/ml - Eye drops, solution -1 bottle autorizzato dall'European Medicines Agency - EMA e identificato con n. EU/1/11/692/001, sono assegnati i seguenti dati identificativi nazionali. Importatore: New Pharmashop S.r.l. con sede legale in Cis Di Nola - Isola 1, Torre 1 - Int. 120 80035 Nola NA. Confezione: YELLOX «0.9 mg/ml - collirio, soluzione - uso oftalmico - flacone (PE) - 5 ml» 1 flacone - codice A.I.C. n. 047766011 (in base 10) 1FKQHV (in base 32);
forma farmaceutica: collirio, soluzione 1 ml di soluzione contiene 0,9 mg di bromfenac (come sodio sesquidrato). Una goccia contiene approssimativamente 33 microgrammi di bromfenac. eccipienti: acido borico, borace, sodio solfito anidro (E221), benzalconio cloruro (vedere paragrafo 2), tiloxapol, povidone (K30), disodio edetato, acqua per preparazioni iniettabili, sodio idrossido (per mantenere i valori di acidita' nella norma). Classificazione ai fini della rimborsabilita' Confezione: YELLOX «0.9 mg/ml - collirio, soluzione - uso oftalmico - flacone (PE) - 5 ml» 1 flacone - codice A.I.C. n. 047766011;
classe di rimborsabilita': C (nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata classe C (nn), nelle more della presentazione da parte del titolare dell'AIP di una eventuale domanda di diversa classificazione. Classificazione ai fini della fornitura Confezione: YELLOX «0.9 mg/ml - collirio, soluzione - uso oftalmico - flacone (PE) - 5 ml» 1 flacone - codice A.I.C. n. 047766011;
RR - medicinale soggetto a prescrizione medica. Stampati...
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