COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Nexplanon» (14A07101)
Estratto determinazione V &
A n. 1763/2014 del 3 settembre 2014 Descrizione del medicinale e attribuzione n. A.I.C.: e' autorizzata l'immissione in commercio del medicinale: «NEXPLANON», anche nella forma e confezione: «5 impianti da 68 mg per uso sottocutaneo», alle condizioni e con le specificazioni di seguito indicate. Titolare A.I.C.: N.V. ORGANON, con sede legale e domicilio fiscale in OSS - Paesi Bassi, Kloosterstraat, 6, CAP 5349 AB, Olanda (NL). Confezione: 5 impianti da 68 mg per uso sottocutaneo - A.I.C. n. 034352029 (in base 10) 10SBWX (in base 32). Forma farmaceutica: impianto per uso sottocutaneo. Composizione: ogni impianto per uso sottocutaneo contiene: principio attivo: Etonogestrel 68 mg. Classificazione ai fini della rimborsabilita' Confezione: A.I.C. n. 034352029 - 5 impianti da 68 mg per uso sottocutaneo. 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: A.I.C. n. 034352029 - 5 impianti da 68 mg per uso sottocutaneo - RNR: medicinale soggetto a prescrizione medica da rinnovare volta per volta. 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 presente determinazione. In ottemperanza all'art. 80 commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e...
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