COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Fluticasone Cipla». (15A04178)
Estratto determina n. 640/2015 del 20 maggio 2015 Medicinale: FLUTICASONE CIPLA. Titolare AIC: Cipla Europe NV . Uitbreidingstraat 80, 2600 Anversa, Belgio Confezione «125 microgrammi/erogazione, sospensione pressurizzata per inalazione» inalatore 120 dosi - AIC n. 043082015 (in base 10) 192S8Z (in base 32) Confezione «250 microgrammi/erogazione, sospensione pressurizzata per inalazione» inalatore 120 dosi - AIC n. 043082027 (in base 10) 192S9C (in base 32) Forma farmaceutica: Sospensione pressurizzata per inalazione. Composizione: Una dose calibrata (dalla valvola) contiene rispettivamente: Principio attivo: 125 o 250 microgrammi di fluticasone propionato. Questo equivale ad una dose erogata (dall'erogatore) rispettivamente di 110 microgrammi o 227 microgrammi di fluticasone propionato. Eccipienti: Norflurano (HFA 134a) Produzione principio attivo: Cipla Limited, Plot No. D-7, D-27, MIDC Industrial Areal, Kurkumbh Village, Taluka-Daund District - Pune, Maharashtra 413802, India Produzione e confezionamento del prodotto finito: Cipla Ltd (Unit II), Plot No. L-139, S-103 e M-62, Verna Industrial Estate, Verna, Goa 403722, India Controllo dei lotti: Select Pharma Laboratories Limited, 55 Stirling Enterprise park, Stirling FK77RP, Regno Unito (Controlli chimici e fisici) Select Bio Laboratories Limited, Biocity Scotland, Bo'ness Road, Motherwell, Lanarkshire ML 15UH, Regno Unito (Controlli microbiologici) Minerva Scientific Limited, Minerva House, Unit 2 Stoney gate Road, Spondon, Derby DE21 7RY, Regno Unito (Controlli chimici e fisici) ILS Ltd, Shardlow Business Park, London Road, Shardlow DE72 2GD, Regno Unito (Controlli microbiologici) Rilascio dei lotti: S&D Pharma CZ, spol. s r.o., Theodor 28, 273 08 Pchery (Pharmos a.s. facility) 27308, Repubblica Ceca Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, Londra, W2 6BY, Regno Unito Indicazioni terapeutiche: Fluticasone Cipla e' indicato per il trattamento di mantenimento dell'asma persistente come terapia profilattica. Fluticasone Cipla non deve...
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