COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Release 300 mg/ml» soluzione iniettabile. (17A06216)
Estratto provvedimento n. 495 del 1° agosto 2017 Medicinale veterinario RELEASE 300 mg/ml soluzione iniettabile. Confezioni e n. A.I.C.: scatola con un flacone da 100 ml - A.I.C. n. 104714011. Titolare A.I.C.: WDT - Wirtschaftsgenossenschaft deutscher Tierärzte eG, Siemensstr. 14 - 30827 Garbsen - Germania. Oggetto del provvedimento: Procedura europea n. DE/V/0125/001/II/005 Aggiunta di due nuove confezioni Si autorizza la modifica come di seguito descritta: scatola con un flacone da 50 ml - A.I.C. n. 104714023;
scatola con 12 flaconi da 50 ml - A.I.C. n. 104714035. Per effetto delle suddette variazioni gli stampati devono essere modificati come segue: RPC Punto 6.5: Natura e composizione del confezionamento primario Flacone multidose da 100 ml, in vetro incolore Tipo I, con tappo in gomma alogeno-butilica e ghiera di alluminio. Disponibile in scatola di cartone contenente 1 o 12 flaconi multidose. Flacone multidose...
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