COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Azitrox». (14A05330)
Estratto determinazione n. 659/2014 del 30 giugno 2014 Medicinale: AZITROX Titolare AIC: Alfra snc di Leonarda Anselmo &
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- Viale Manzoni, 59 - 00185 Roma - Italia Confezione: «500 mg compressa rivestita con film» 3 compresse - AIC n. 042433019 (in base 10) 18GYHV (in base 32) Forma farmaceutica: Compresse rivestite con film. Composizione: Ogni compressa contiene: Principio attivo: 524 mg di azitromicina diidrato pari a 500 mg di azitromicina. Eccipienti: Nucleo della compressa: calcio idrogeno fosfato anidro ipromellosa (E464) croscarmellosa sodica magnesio stearato (E470b) amido pregelatinizzato (mais) sodio laurilsolfato Rivestimento: ipromellosa lattosio monoidrato titanio diossido (E171) triacetina. Produzione principio attivo: Jubilant Life Sciences Limited - Plot n. # 18, 56, 57 &
58 Kiadb Industrial Area - Nanjangud - 571 302 - Mysore District - Karnataka - India Produzione, confezionamento primario e secondario: Jubilant Life Sciences Limited - Village Sikandarpur Bhainswal - Roorkee - Dehradoon Highway - Bhagwanpur, Roorkee - Distt. - Haridwar - Uttrakhand - 247 661 - India Controllo lotti: Kennet Bioservices Ltd. - 6 Kingsdown Orchard-Hyde Road-Swindon- Wiltshire SN2 7RR - Regno Unito MCS Laboratories Limited - Unit 8 &
9-Rockmill Business Park, The Dale, Stoney Middleton - Hope Valley, South Yorkshire, S32 4TF - Regno Unito Zeta Analytical Ltd. - Unit 3 -Colonial Way - Watford - Herts -WD24 4YR - Regno Unito Rilascio lotti: PSI Supply nv -Axxes Business Park - Guldensporenpark 22-Block C - 9820 Merelbeke - Belgio Indicazioni terapeutiche: Trattamento delle infezioni causate da germi sensibili all'azitromicina: infezioni delle alte vie respiratorie (incluse otiti medie, sinusiti, tonsilliti e faringiti);
infezioni delle basse vie respiratorie (incluse bronchiti e polmoniti);
infezioni odontostomatologiche;
infezioni della cute e dei tessuti molli;
uretriti non gonococciche (da Chlamydia trachomatis);
ulcera molle (da Haemophilus ducreyi). Devono essere prese in considerazione le linee guida ufficiali sull'uso appropriato degli...
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