COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Latanoprost Mylan» (15A05638)
Estratto determina n. 885/2015 del 13 luglio 2015 Medicinale: LATANOPROST MYLAN. Titolare AIC: Mylan S.p.A. - Via Vittor Pisani 20 - 20124 Milano Italia. Confezioni: "50 microgrammi/ml collirio, soluzione" 1 flacone HDPE da 2,5 ml - AIC n. 042620017 (in base 10) 18NP3K (in base 32);
"50 microgrammi/ml collirio, soluzione" 3 flaconi HDPE da 2,5 ml - AIC n. 042620029 (in base 10) 18NP3X (in base 32);
"50 microgrammi/ml collirio, soluzione" 6 flaconi HDPE da 2,5 ml - AIC n. 042620031 (in base 10) 18NP3Z (in base 32). Forma farmaceutica: Collirio, soluzione. Composizione: Un ml di collirio contiene: Principio attivo: 50 microgrammi di Iatanoprost. Eccipienti: Cloruro di sodio, Benzalconio cloruro, Sodio fosfato monobasico monoidrato, Sodio fosfato bibasico anidro, acqua per preparazioni iniettabili. Produttore del principio attivo: Laurus Labs Private Limited - Plot No. DS1, ICICI Knowledge Park, Turkapally, Shameerpet (MD), Ranga Reddy, Hyderabad, Andhra Pradesh - 500 078 - India. Mylan Laboratories Limited (Unit 3) - Plot Nos. 35, 36, 38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla, Hyderabad - 500055, Andhra Pradesh - India. Produzione del Bulk, confezionamento primario e secondario: Wintac Limited, # 54/1, Boodhihal Village, Nelamangala - Taluk, Nelamangala Bangalore - 562123, Karnataka - India. Confezionamento secondario: DHL Supply Chain (Italy) S.p.A (solo per IT) - Viale Delle Industrie 2 - 20090 Settala (MI) Italia. Sterilizzazione del materiale di confezionamento primario: Ionisos SAS - Parc Dombes Cotiere activities, 01120 Dagneux Francia. Synergy Health Daniken AG, Hogenweidstrasse 6, 4658 Danika Svizzera. Controllo dei lotti: APL Swift Services - HF26, Hal Far Industrial estate, Hal Far - Birzebbugia, BBG 3000, Malta. Rilascio dei lotti: Mylan S.A.S - 117 Allee des Parcs, 69 800 Saint Priest, Francia. Indicazioni terapeutiche: Riduzione della pressione intraoculare elevata in pazienti con glaucoma ad angolo aperto ed ipertensione oculare. Riduzione della pressione intraoculare elevata nei pazienti pediatrici con elevata pressione intraoculare e glaucoma pediatrico. Classificazione ai fini della rimborsabilita' Confezione: "50 microgrammi/ml collirio, soluzione" 1 flacone HDPE da 2,5 ml. AIC n. 042620017 (in base 10) 18NP3K (in base 32). Classe di...
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