COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Nizoral». (16A01124)
Estratto determina V&A n. 147/2016 del 26 gennaio 2016 Descrizione del medicinale e attribuzione n. AIC E' autorizzata l'immissione in commercio del medicinale: NIZORAL nella forma e confezione: "20 mg/g shampoo" flacone da 100 g, in sostituzione alle confezioni gia' autorizzate, alle condizioni e con le specificazioni di seguito indicate: Titolare AIC: Johnson &
Johnson S.p.A., Via Ardeatina, Km 23,500, 00071 - Santa Palomba - Pomezia - Roma (RM) Italia, codice fiscale 00407560580 Confezione: "20 mg/g shampoo" flacone da 100 g AIC n. 024964140 (in base 10) 0RTV1D (in base 32) Forma Farmaceutica: shampoo Composizione: un grammo di NIZORAL shampoo contiene: Principio Attivo: ketoconazolo 20,00 mg. Classificazione ai fini della rimborsabilita' Confezione: "20 mg/g shampoo" flacone da 100 g AIC n. 024964140 Classe di rimborsabilita': C-BIS Classificazione ai fini della fornitura Confezione: "20 mg/g shampoo" flacone da 100 g AIC n. 024964140 - OTC: medicinali non soggetti a prescrizione medica da banco 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 determinazione...
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