COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Ezetimibe e Simvastatina Teva» (18A07943)
Estratto determina n. 1875/2018 del 27 novembre 2018 Medicinale: EZETIMIBE E SIMVASTATINA TEVA. Titolare AIC: Teva Italia S.r.l., piazzale Luigi Cadorna n. 4, 20123 Milano, Italia. Confezioni: «10 mg/10 mg compresse» 14 compresse in flacone Hdpe - A.I.C. n. 044765675 (in base 10);
10 mg/10 mg compresse
28 compresse in flacone Hdpe - A.I.C. n. 044765687 (in base 10);
10 mg/10 mg compresse
50 compresse in flacone Hdpe - A.I.C. n. 044765699 (in base 10);
10 mg/10 mg compresse
98 compresse in flacone Hdpe - A.I.C. n. 044765701 (in base 10). Forma farmaceutica: compresse. Composizione: Principio attivo: ezetimibe e simvastatina 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 «Ezetimibe e Simvastatina Teva» e' la seguente: medicinale soggetto a prescrizione medica (RR). Tutela brevettuale Il titolare dell'AIC 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'AIC 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...
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