COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Primidone Auden». (15A07779)
Estratto determina n. 1275/2015 dell'8 ottobre 2015 Medicinale: PRIMIDONE AUDEN. Titolare A.I.C.: Auden Mckenzie (Pharma Division) Ltd - Operante anche come Auden - McKenzie House - Bury Street - Ruislip - Middlesex - HA4 7TL - Regno Unito. Confezione: "50 mg compresse" 100 compresse in blister PVC/Al - AIC n. 043835014 (in base 10) 19TRN6 (in base 32) Confezione: "250 mg compresse" 100 compresse in blister PVC/Al - AIC n. 043835026 (in base 10) 19TRNL (in base 32) Forma farmaceutica: compressa. Composizione: ogni compressa contiene: Principio attivo: 50 mg, 250 mg di primidone. Eccipienti: Lattosio monoidrato Cellulosa microcristallina Glicolato di amido di sodio (tipo A) Povidone K30 Sodio lauril solfato Silice anidra colloidale Acido stearico Magnesio stearato Produzione principio attivo: Nantong Jinghua Pharmaceutical Co Ltd - 43 yaogang road - Jiangsu Province 226006 Nantong - 226006 Nantong - Cina Nantong Jinghua Pharmaceutical Co Ltd - 2-02 crossroad between 3 Haibin Road and 2 Tinghai Road - Yanhai Economic - Development Zone - Rudong - Jiangsu Province 226407 Nantong - 226407 Cina Produzione, controllo lotti, rilascio lotti: Tiofarma BV - Benjamin Franklinstraat 7-9 3261 LW Oud-Beijerland - 3261 - Olanda. Controllo lotti: Bactimm BV - Middenkamweg 19, 6545 CH Nijmegen PO Box 6876 - 6503 GJ Nijimegen - 6503 Olanda. Confezionamento primario e secondario: Tjoapack BV - Columbusstraat 4, 7825 VR Emmen - 7825 Olanda. Indicazioni terapeutiche: Primidone e' indicato nella gestione dell'epilessia tipo grande male e psicomotoria (lobo temporale). E' anche utile nella gestione delle convulsioni focali o jacksoniane, degli attacchi mioclonici e degli attacchi acinetici. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano...
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