COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Sumatriptan Teva». (14A07027)
Estratto determinazione V &
A n. 1739/2014 del 1º settembre 2014 Descrizione del medicinale e attribuzione n. AIC: e' autorizzata l'immissione in commercio del medicinale: SUMATRIPTAN TEVA nella forma e confezione: «100 mg compresse rivestite con film» 24 compresse in blister PVC/PVDC/AL, in aggiunta alle confezioni gia' autorizzate, alle condizioni e con le specificazioni di seguito indicate. Titolare AIC: Teva Italia S.r.l., con sede legale e domicilio fiscale in via Messina n. 38 - cap. 20154 Milano, codice fiscale 11654150157. Confezione: «100 mg compresse rivestite con film» 24 compresse in blister PVC/PVDC/AL - AIC n. 037998186 (in base 10) 147MMB (in base 32). Forma farmaceutica: compressa rivestita con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: 100 mg di sumatriptan (come sumatriptan succinato). Classificazione ai fini della rimborsabilita' Confezione: «100 mg compresse rivestite con film» 24 compresse in blister PVC/PVDC/AL - AIC n. 037998186 (in base 10) 147MMB (in base 32). Classe di rimborsabilita' 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). Classificazione ai fini della fornitura Confezione: «100 mg compresse rivestite con film» 24 compresse in blister PVC/PVDC/AL - AIC n. 037998186 (in base 10) - RR: Medicinale soggetto a prescrizione medica. Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come precedentemente autorizzati da questa Amministrazione, con le sole modifiche necessarie per l'adeguamento alla determinazione, di cui al presente estratto. In ottemperanza all'art. 80 commi 1 e 3 del decreto...
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