COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Azylung». (16A03524)
Estratto determina n. 540/2016 del 20 aprile 2016 Medicinale: AZYLUNG. Titolare AIC: INCA-Pharm S.r.l. - Via Dante Alighieri, 3 - 03100 Frosinone. Confezione: «500 mg polvere per soluzione per infusione» 1 flaconcino in vetro;
A.I.C. n. 044273011 (in base 10) 1B73CM (in base 32). Forma farmaceutica: Polvere per soluzione per infusione. Composizione: Ogni flaconcino contiene: Principio attivo: 500 mg di azitromicina (equivalenti a 524,03 mg di azitromicina diidrato) che dopo ricostituzione corrispondono a 100 mg/ml di soluzione di azitromicina. Il concentrato deve essere inoltre diluito a 1 mg/ml o 2 mg/ml. Eccipienti: Acido citrico anidro Sodio idrossido al 30% (per aggiustare il pH) Produttori del principio attivo: Ercros S.A. - Paseo del Deleite s/n - Aranjuez, 28300 Madrid - Spagna;
Jubilant Generics Limited N. 18, 56, 57 &
58, KIADB Industrial Area, Mysore District 571 302 Nanjangud, Karnataka - India. Produzione, confezionamento primario e secondario, controllo e rilascio dei lotti: Laboratorio Reig Jofre', S.A. - Gran Capitan 10 - 08970 Sant Joan Despi', Barcellona - Spagna. Controllo e rilascio dei lotti: Tecnimede - Sociedade Tecnico-Medicinal, S.A. - Quinta da Cerca, Caixaria 2565-187 Dois Portos - Portogallo. Indicazioni terapeutiche: Azylung 500 mg polvere per soluzione per infusione e' indicato nel trattamento della polmonite acquisita in comunita' causata da microrganismi sensibili, in pazienti adulti che richiedono una terapia iniziale endovenosa. Azylung 500 mg polvere per soluzione per infusione e' indicato nel trattamento della malattia infiammatoria pelvica (MIP) causata da microrganismi sensibili, in pazienti che richiedono una terapia iniziale endovenosa. Si deve tenere in considerazione la linea guida ufficiale concernente l'uso appropriato di agenti antibatterici. Classificazione ai fini della rimborsabilita' Confezione: «500 mg polvere per...
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