COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Avamys» (20A05221)
Estratto determina IP n. 421 del 14 luglio 2020 Al medicinale AVAMYS 27,5 µl/spray - nasal spray, suspension - 1 bottle autorizzato dall' European Medicines Agency - EMA e identificato con n. EU/1/07/434/002, sono assegnati i seguenti dati identificativi nazionali. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta, 2 - 20090 Segrate (Milano). Confezione: AVAMYS «27,5 mcg/erogazione spray nasale sospensione - uso endonasale» 1 flacone (vetro) in erogatore plastica 60 erogazioni - codice A.I.C. n. 046119020 (in base 10), 1CZG3D (in base 32). Forma farmaceutica: spray nasale sospensione. Ciascuna erogazione fornisce 27,5 microgrammi di fluticasone furoato. Eccipienti: glucosio anidro, cellulosa dispersibile, polisorbato 80, benzalconio cloruro, disodio edetato, acqua depurata. Classificazione ai fini della rimborsabilita' Confezione: AVAMYS «27,5 mcg/erogazione spray nasale sospensione - uso endonasale» 1 flacone (vetro) in erogatore plastica 60 erogazioni - codice A.I.C. n. 046119020;
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: AVAMYS «27,5 mcg/erogazione spray nasale sospensione - uso endonasale» 1 flacone (vetro) in erogatore plastica 60 erogazioni - codice A.I.C. n. 046119020;
RR - medicinale soggetto a prescrizione medica. Stampati Le confezioni del medicinale importato devono...
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