COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Xorox» (19A04130)
Estratto determina n. 975/2019 dell'11 giugno 2019 Medicinale: XOROX. Titolare A.I.C.: Agepha Pharma s.r.o - Dialnicna' cesta 5 - Senec 903 01 - Slovacchia. Confezione: «30 mg/g unguento oftalmico» 1 tubo in AL da 4,5 g - A.I.C. n. 047616014 (in base 10). Forma farmaceutica: unguento oftalmico. Validita' prodotto integro: tre anni. Condizioni particolari di conservazione: conservare a temperatura inferiore a 25°C. Composizione: principio attivo: 1 g di unguento contiene 30 mg di aciclovir;
eccipienti: paraffina morbida bianca. Produttore del principio attivo: Olon S.p.a. - via Scaldasole n. 33 - 27020 Dorno - Pavia Italia. Produttore del prodotto finito: produzione: Wagner Pharma KFT. IV. körzet 5. - Kunfeherto' 6413 - Ungheria;
confezionamento primario: Wagner Pharma KFT. - IV. körzet 5. - Kunfeherto' 6413 - Ungheria;
confezionamento secondario: Wagner Pharma KFT. - IV. körzet 5. - Kunfeherto' 6413 - Ungheria;
controllo di qualita': Wagner Pharma KFT. - IV. körzet 5. - Kunfeherto' 6413 - Ungheria;
Eurofins Bel/Novamann s.r.o - Kollarovo nam. 9 - 81107 Bratislava 1 - Slovacchia;
Eurofins Bel/Novamann s.r.o - Mudroňova 2388/25 - 92101 Pieštany -Slovacchia. Rilascio dei lotti: Agepha Pharma s.r.o - Dial'nična' cesta 5 - 903 01 Senec - Slovacchia. Indicazioni terapeutiche: «Xorox» 30 mg/g unguento oftalmico e' indicato per il trattamento della cheratite da herpes simplex. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 sono collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, denominata classe C (nn). Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale «Xorox» e'...
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