COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Dicloreum Dolore». (14A05346)
Estratto determinazione V &
A n. 1372/2014 del 1° luglio 2014 Descrizione del medicinale e attribuzione n. AIC E' autorizzata l'immissione in commercio del medicinale: ''DICLOREUM DOLORE'', nella forma e confezione: "25 mg granulato per soluzione orale" 10 bustine in carta/al/pe;
in aggiunta alle confezioni gia' autorizzate, 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 - Codice Fiscale 00556960375;
Confezione: «25 mg granulato per soluzione orale» 10 bustine in carta/al/pe - AIC n. 028618041 (in base 10) 0V9C9T (in base 32). Forma Farmaceutica: granulato per soluzione orale. Composizione: 1 bustina di granulato per soluzione orale contiene: Principio Attivo: diclofenac idrossietilpirrolidina 32,5 mg (pari a 25 mg di diclofenac sodico) Classificazione ai fini della rimborsabilita' Confezione: AIC n. 028618041 - "25 mg granulato per soluzione orale" 10 bustine in carta/al/pe 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. 028618041 - "25 mg granulato per soluzione orale" 10 bustine in carta/al/pe - OTC: medicinale non soggetto a prescrizione medica da banco Stampati Le confezioni del medicinale devono essere poste in commercio con gli stampati cosi' come precedentemente autorizzati da...
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