COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Dovobet». (13A09052)
Estratto determinazione V &
A n. 1760/2013 del 28 ottobre 2013 Descrizione del medicinale e attribuzione n. AIC. E' autorizzata l'immissione in commercio del medicinale DOVOBET nella forma e confezione: «50 mcg + 0,5 mg/g gel» 3 flaconi LDPE da 60 g, in aggiunta alle confezioni gia' autorizzate, alle condizioni e con le specificazioni di seguito indicate. Titolare AIC: Leo Pharma A/S, Industriparken 55, DK-2750 Ballerup, Danimarca. Confezione: «50 mcg + 0,5 mg/g gel» 3 flaconi LDPE da 60 g. AIC n. 035675178 (in base 10) 120R1B (in base 32). Forma Farmaceutica: Gel. Composizione: un grammo di gel contiene: Principio Attivo: Calcipotriolo (come monoidrato) e betametasone (come dipropionato). Classificazione ai fini della rimborsabilita' Confezione: «50 mcg + 0,5 mg/g gel» 3 flaconi LDPE da 60 g. AIC n. 035675178 (in base 10) 120R1B (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: «50 mcg + 0,5 mg/g gel» 3 flaconi LDPE da 60 g. AIC n. 035675178 (in base 10) 120R1B (in base 32). 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 presente determinazione. In ottemperanza all'art. 80...
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