COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Flecainide Doc generici». (15A03077)
Estratto determina n. 405/2015 del 13 aprile 2015 Medicinale: FLECAINIDE DOC Generici. Titolare AIC: DOC Generici S.r.l. - Via Turati 40 - 20121 Milano. Confezione: «100 mg compresse» 20 compresse in blister PVC/PVDC/AL AIC n. 043544016 (in base 10) 19JVGJ (in base 32). Forma farmaceutica: compressa. Composizione: ogni compressa contiene: Principio attivo: 100 mg di flecainide acetato. Eccipienti: Cellulosa microcristallina (E460) Croscarmellosa sodica Amido pregelatinizzato Olio vegetale idrogenato Magnesio stearato (E572) Produzione principio attivo: Unimark Remedies Limited - Plot No. 41/42, Phase I- G.I.D.C, Vapi, Valsad District, Gujarat - 396195 India. Produzione e confezionamento: Aurobindo Pharma Limited - Unit VII (SEZ) - SEZ APIIC, Plot No. S1 (Part), Survey.Nos. 411, 425, 434, 435, 458, Green Industrial Park, Polepally village, Jedcherla Mandal, Mahaboob Nagar District- 509302, Andhra Pradesh - India. Controllo e rilascio lotti: APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 - Malta. Rilascio lotti: Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, South Ruislip HA4 6QD - Regno Unito. Controllo lotti: Zeta Analytical Limited - Colonial Way, Unit 3, Watford, Hertfordshire, WD24 4YR - Regno Unito. Confezionamento secondario: Silvano Chiapparoli Logistica S.p.A. - Via delle Industrie Snc, 26814 Livraga - Lodi - Italia. Indicazioni terapeutiche: Trattamento della tachicardia nodale reciprocante atrioventricolare;
aritmie associate a sindrome di Wolff-Parkinson-White e condizioni simili con vie di conduzione accessorie, quando altri trattamenti sono risultati inefficaci. Trattamento della aritmia ventricolare parossistica sintomatica grave e potenzialmente fatale che non ha risposto ad altre forme di terapia o nel caso in cui altri trattamenti non siano stati tollerati. Trattamento delle aritmie atriali parossistiche (fibrillazione atriale, flutter atriale e tachicardia atriale) in pazienti con sintomi invalidanti dopo conversione, posto che vi...
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