COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Labiriad» (13A09879)
Estratto determinazione V &
A n. 2084 del 25 novembre 2013 Descrizione del medicinale e attribuzione n. A.I.C. E' autorizzata l'immissione in commercio del medicinale: «LABIRIAD», nella forma e confezione: «50 mg compresse buccali mucoadesive» 2x1 compresse in blister monodose AL/AL, alle condizioni e con le specificazioni di seguito indicate. Titolare A.I.C.: Bioalliance Pharma SA, con sede legale e domicilio fiscale in Paris-Francia, Immeuble Les Chevrons, 49 Boulevard Du General Martial Valin, cap 75015, Francia (FR). Confezione: «50 mg compresse buccali mucoadesive» 2x1 compresse in blister monodose AL/AL - A.I.C. n. 041535016 (in base 10) 17MKK8 (in base 32). Forma Farmaceutica: compressa buccale mucoadesiva. Validita' Prodotto Integro: 2 anni dalla data di fabbricazione. Produttori del principio attivo: Olon S.p.A. stabilimento sito in 26837 Cassino d'Alberi - Mulazzano Lodi, Via della Vittoria n. 89. Produttore del prodotto finito: Unither Development Bordeaux Zone d'Activite' Tech Espace Avenue Toussaint Catros - 33 186 Le Haillan - Francia (produzione del prodotto finito);
Farmea 10, rue Bouche' Thomas - ZAC d'Orgemont 49000 Angers - Francia (confezionamento primario e secondario, controllo lotti e rilascio dei lotti). Composizione: Ogni compressa da 50 mg contiene: principio attivo: Aciclovir 50 mg;
eccipienti: Cellulosa microcristallina;
Povidone;
Ipromellosa;
Concentrato di proteine del latte con residui di lattosio;
Silice colloidale anidra;
Sodio laurilsolfato;
Magnesio stearato. Indicazioni terapeutiche: Labiriad e' indicato per il trattamento dell'herpes labialis ricorrente nei pazienti adulti immunocompetenti affetti da episodi frequenti di herpes. Classificazione ai fini della rimborsabilita'. Confezione: A.I.C. n. 041535016 - «50 mg compresse buccali mucoadesive» 2x1 compresse in blister monodose AL/AL. 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...
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