COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nizoral» (18A05519)
Estratto determina IP n. 578 del 31 luglio 2018 E' autorizzata l'importazione parallela del medicinale NIZORAL 2% Shampoo 120 ml dalla Gran Bretagna con numero di autorizzazione PL 00242/0139, intestato alla societa' Janssen-Cilag Limited (UK) e prodotto da Janssen Pharmaceutica NV-SA (BE) con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.R.L. con sede legale in via Lambretta 2, 20090 Segrate (MI). Confezione: «Nizoral» «20 mg/g shampoo» flacone da 120 ml. Codice A.I.C.: 046601011 (in base 10) 1DG4TM (in base 32). Forma farmaceutica: Shampoo. Composizione: un grammo di «Nizoral» shampoo contiene: principio attivo: Ketoconazolo 20,00 mg;
eccipienti: Sodio lauril etere solfato;
lauril semisolfosuccinato bisodico;
coccoildietanolamide;
laurdimonium idrolizzato (collagene animale);
macrogol 120 metilglucosio dioleato;
profumo;
imidazolidinilurea;
acido cloridrico;
sodio cloruro;
sodio idrossido;
eritrosina;
acqua depurata. Indicazioni terapeutiche: trattamento delle infezioni del cuoio capelluto che implicano il lievito Malassezia (in precedenza chiamato Pityrosporum), come la dermatite seborroica localizzata e la pityriasis capitis (forfora). «Nizoral» shampoo puo' essere usato dagli adulti e dagli adolescenti (12-18 anni). Officine di confezionamento secondario CIT S.R.L. via Primo Villa n. 17, 20875 Burago di Molgora...
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