COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Losartan Aurobindo». (16A00118)
Estratto determina n. 1695/2015 del 23 dicembre 2015 Medicinale: LOSARTAN AUROBINDO. Titolare A.I.C.: Aurobindo Pharma (Italia) s.r.l. - Via San Giuseppe, 102 - 21047 Saronno (Varese) - Italia. Confezione: «25 mg compresse rivestite con film » 56 compresse in blister Pvc/Pe/Pvdc-Al - A.I.C. n. 043614167 (in base 10) 19LZYR (in base 32);
confezione: «50 mg compresse rivestite con film» 56 compresse in blister Pvc/Pe/Pvdc-Al - A.I.C. n. 043614179 (in base 10) 19LZZ3 (in base 32);
confezione: «100 mg compresse rivestite con film» 56 compresse in blister Pvc/Pe/Pvdc-Al - A.I.C. n. 043614181 (in base 10) 19LZZ5 (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: 25 mg, 50 mg, 100 mg di losartan. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, denominata classe C (nn). Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale «Losartan Aurobindo» e' la seguente: Medicinale soggetto a prescrizione medica...
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