Autorizzazione all'immissione in commercio della specialita' medicinale per uso umano
Estratto determinazione n. 264 del 19 luglio 2006
Medicinale: ZINDACLIN.
Titolare A.I.C.: Difa Cooper S.p.a., via Milano, 160 - Caronno Pertusella - 21042 Varese.
Confezioni:
1% gel 15 g in tubo laminato - A.I.C. n. 0368620111M (in base 10), 134Y1V (in base 32);
1% gel 30 g in tubo laminato - A.I.C. n. 036862023/M (in base 10), 134Y27 (in base 32);
1% gel 60 g in tubo laminato - A.I.C. n. 036862035/M (in base 10) 134Y2M (in base 32).
Forma farmaceutica: gel.
Composizione: 1 g di gel:
principio attivo: 10 mg di clindamicina (1% w/w) pari a 11,88 mg di clindamicina fosfato;
eccipienti: glicole propilenico, acqua depurata, etanolo 96%, zinco acetato diidrato, idrossietilcellulosa, sodio idrossido 30% (w/w).
Produzione confezionamento e rilascio dei lotti: Dr. August Wolf GmbH & Co. Arzneimittel - Sudbrackstrasse, 56 - 33611 Bielefeld - Germany.
Indicazioni terapeutiche: ´Zindaclinª e' indicato nel trattamento dell'acne volgare di lieve e modesta gravita'.
Classificazione ai fini della rimborsabilita'.
Confezioni:
1% gel 15 g in tubo laminato - A.I.C. n. 036862011/M (in base 10), 134Y1V(in base 32);
classe di rimborsabilita': ´Cª;
1% gel 30 g in tubo laminato - A.I.C. n. 036862023/M (in base 10), 134Y27 (in base 32);
classe di rimborsabilita': ´Cª;
1% gel 60 g in tubo laminato - A.I.C. n. 036862035/M (in base 10), 134Y2M (in base 32);
classe di rimborsabilita': ´Cª.
Classificazione ai fini della fornitura: RR: medicinale soggetto a prescrizione medica.
Stampati: le confezioni della specialita' medicinale devono essere poste in commercio con etichette e fogli illustrativi conformi al...
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