COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Bupivan». (15A08548)
Estratto determina V&A n. 2087/2015 del 28 ottobre 2015 Descrizione del medicinale e attribuzione n. A.I.C. E' autorizzata l'immissione in commercio del medicinale: «BUPIVAN», anche nella forme e confezioni: «2,5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml e «5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml, alle condizioni e con le specificazioni di seguito indicate: Titolare A.I.C.: Claris Lifesciences (UK) Limited, con sede legale e domicilio fiscale in Cheshire - Gran Bretagna, Crewe Hall, Golden Gate Lodge, Crewe, Cap CWI 6UL, Gran Bretagna (GB). Confezione: «2,5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml - A.I.C. n. 041899055 (in base 10) 17YP1H (in base 32). Confezione: «5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml - A.I.C. n. 041899067 (in base 10) 17YP1V (in base 32). Forma farmaceutica: soluzione iniettabile. Per la confezione da 2,5 mg/ml. Composizione: 1 ml di soluzione iniettabile contiene: Principio attivo: 1 ml contiene 2,5 mg di bupivacaina cloridrato monoidrato. 1 flaconcino di soluzione da 10 ml contiene 25 mg di bupivacaina cloridrato monoidrato. Per la confezione da 5 mg/ml. Composizione: 1 ml di soluzione iniettabile contiene: Principio attivo: 1 ml contiene 5 mg di bupivacaina cloridrato monoidrato. 1 flaconcino di soluzione da 10 ml contiene 50 mg di bupivacaina cloridrato monoidrato. Classificazione ai fini della rimborsabilita' Confezione: A.I.C. n. 041899055 - «2,5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml. Classe di rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata Classe C (nn). Confezione: A.I.C. n. 041899067 - «5 mg/ml soluzione iniettabile» 10 flaconcini in vetro da 10 ml. Classe di rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre...
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