COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Dicloreum Actigel». (14A02787)
Estratto determinazione V &
A n. 495/2014 del 7 marzo 2014 Descrizione del medicinale e attribuzione n. AIC. E' autorizzata l'immissione in commercio del medicinale: DICLOREUM ACTIGEL, anche nella forma e confezione: «1% gel» tubo da 100 g, alle condizioni e con le specificazioni di seguito indicate. Titolare AIC: ALFA WASSERMANN S.p.A. con sede legale e domicilio fiscale in Via Enrico Fermi, 1, 65020 - ALANNO - PESCARA (PE) Italia, Codice Fiscale 00556960375. Confezione: «1% gel» tubo da 100 g AIC n. 035450028 (in base 10) 11TV5D (in base 32) Forma Farmaceutica: gel Composizione: Un tubo di gel contiene: Principio Attivo: Diclofenac Idrossietilpirrolidina 1 g Classificazione ai fini della rimborsabilita' Confezione: AIC n. 035450028 - «1% gel» tubo da 100 g 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. 035450028 - «1% gel» tubo da 100 g - OTC: medicinale non soggetto a prescrizione medica da banco. Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come...
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