COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Metformina Hexal AG». (19A02520)
Estratto determina n. 570/2019 del 2 aprile 2019 Medicinale: METFORMINA HEXAL AG. Titolare A.I.C.: Hexal AG. Confezione: «850 mg compresse rivestite con film» 90 compresse in blister PVC/AL - A.I.C. n. 038828366 (in base 10);
Forma farmaceutica: compresse rivestite con film. Principio attivo: Metformina cloridrato. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 sono 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 «Metformina Hexal AG» e' la seguente: medicinale soggetto a prescrizione medica (RR). Tutela brevettuale Il titolare dell'A.I.C. del farmaco generico e' esclusivo responsabile del pieno rispetto dei diritti di proprieta' industriale relativi al medicinale di riferimento e delle vigenti disposizioni normative in materia brevettuale. Il titolare dell'A.I.C. del farmaco generico e' altresi' responsabile del pieno rispetto di quanto disposto dall'art. 14, comma 2 del decreto legislativo n. 219/2006 che impone di non includere negli stampati quelle parti del riassunto delle caratteristiche del prodotto del...
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