COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Carexidil». (15A09300)
Estratto determina V &
A n. 2225/2015 del 23 novembre 2015 Descrizione del medicinale e attribuzione n. AIC E' autorizzata l'immissione in commercio del medicinale: CAREXIDIL, anche nella forma e confezione: "2% spray cutaneo, soluzione" 1 flacone in HDPE da 60 ml dotato di pompa dosatrice, alle condizioni e con le specificazioni di seguito indicate: Titolare AIC: DIFA COOPER S.p.A. con sede legale e domicilio fiscale in Via Milano, 160, 21042 - Caronno Pertusella - Varese (VA) Italia - Codice Fiscale 00334560125. Confezione: "2% spray cutaneo, soluzione" 1 flacone in HDPE da 60 ml dotato di pompa dosatrice AIC n. 037291046 (in base 10) 13L116 (in base 32) Forma farmaceutica: spray cutaneo, soluzione Validita' Prodotto Integro: 3 anni dalla data di fabbricazione Produttore del principio attivo: Flamma S.p.A. Via Bedeschi, 22 - 24040 Chignolo D'Isola (BG);
Produttore del prodotto finito: INDUSTRIAL FARMACEUTICA CANTABRIA S.A., stabilimento sito in CARRETERA CAZONA-ADARZO s/n 39011 - SANTANDER - SPAGNA (produzione, confezionamento controllo e rilascio dei lotti). Composizione: Un ml di soluzione contiene: Principio Attivo: Minoxidil 20 mg Eccipienti: Alcool etilico, glicole propilenico e acqua depurata . Indicazioni terapeutiche: CAREXIDIL e' indicato nel trattamento sintomatico dell'alopecia androgenetica. Non e' stata determinata l'efficacia di Carexidil nelle seguenti forme: alopecia congenita localizzata o generalizzata;
Alopecia cicatriziale di varia natura (post-traumatica, di origine psichica o infettiva);
alopecia acuta diffusa da sostanze tossiche, da medicamenti in cui la ricrescita di capelli e' condizionata dalla soppressione della causa specifica;
area celsi. Classificazione ai fini della rimborsabilita' Confezione: AIC n. 037291046 - "2% spray cutaneo, soluzione" 1 flacone in HDPE da 60 ml dotato di pompa dosatrice Classe di rimborsabilita': "C" Classificazione ai fini della fornitura Confezione: AIC n. 037291046 - "2% spray cutaneo...
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