COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Dages». (15A02471)
Estratto determina n. 305/2015 del 23 marzo 2015 Medicinale: DAGES. Titolare A.I.C.: PharmaCare S.r.l. - Via Marghera, 29 - 20149 Milano. Confezioni: «10 mg capsule rigide gastroresistenti» 28 capsule in blister AL/AL - A.I.C. n. 042276042 (in base 10) 18B56B (in base 32);
20 mg capsule rigide gastroresistenti
28 capsule in blister AL/AL - A.I.C. n. 042276055 (in base 10) 18B56R (in base 32);
40 mg capsule rigide gastroresistenti
28 capsule in blister AL/AL - A.I.C. n. 042276067 (in base 10) 18B573 (in base 32). Forma farmaceutica: Capsule rigide gastroresistenti. Composizione: ogni capsula rigida gastroresistente contiene: principio attivo: 10 mg, 20 mg, 40 mg di omeprazolo. Classificazione ai fini della rimborsabilita' Confezione: «10 mg capsule rigide gastroresistenti» 28 capsule in blister AL/AL - A.I.C. n. 042276042 (in base 10) 18B56B (in base 32). Classe di rimborsabilita': C. Confezione: «20 mg capsule rigide gastroresistenti» 28 capsule in blister AL/AL - A.I.C. n. 042276055 (in base 10) 18B56R (in base 32). Classe di rimborsabilita': C. Le confezioni di cui all'art. 1, che non siano classificate in fascia di rimborsabilita' ai sensi del presente articolo, 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...
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