COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Balfolic». (13A10552)
Estratto determinazione V &
A n. 2161 del 10 dicembre 2013 Descrizione del medicinale e attribuzione n. AIC E' autorizzata l'immissione in commercio del medicinale: "BALFOLIC", nella forma e confezione: "400 microgrammi compresse" 120 compresse, alle condizioni e con le specificazioni di seguito indicate: Titolare AIC: LABORATORI BALDACCI S.p.A. con sede legale e domicilio fiscale in Via S. Michele degli Scalzi, 73, 56100 - PISA (PI) Italia, Codice Fiscale 00108790502. Confezione: "400 microgrammi compresse" 120 compresse AIC n. 042186015 (in base 10) 187F8Z (in base 32) Forma Farmaceutica: Compressa Validita' Prodotto Integro: 3 anni dalla data di fabbricazione Produttori del principio attivo: DSM Nutritional Products Ltd - Branch Site Sisseln, Hauptstrasse 4, CH-4334 Sisseln, Svizzera. Produttore del prodotto finito: LABORATORI BALDACCI S.p.A. stabilimento sito in PISA, Via S. Michele degli Scalzi, 73 (produzione del prodotto finito, confezionamento primario e secondario, controllo lotti e rilascio dei lotti). Composizione: Una compressa contiene: Principio Attivo: Acido folico 400 microgrammi Eccipienti: Carbossimetilamido sodico (tipo A);
Cellulosa microcristallina;
Lattosio monoidrato;
Magnesio stearato Indicazioni terapeutiche: Prevenzione primaria dei difetti del tubo neurale del nascituro in donne in eta' fertile che stanno pianificando una gravidanza. Classificazione ai fini della rimborsabilita' Confezione: AIC n. 042186015 - "400 microgrammi compresse" 120 compresse 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: AIC n. 042186015 - "400 microgrammi compresse" 120 compresse - RR: medicinale soggetto a prescrizione...
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