COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Adrenalina Aguettant» (16A04829)
Estratto determina n. 805/2016 del 10 giugno 2016 Medicinale: ADRENALINA AGUETTANT. Titolare A.I.C.: Laboratoire Aguettant. 1 rue Alexander Fleming - 69007 Lione - Francia (FR). Confezione: «1 mg/10 ml (1:10.000) soluzione iniettabile in siringa preriempita» 1 siringa preriempita in PP senza ago - A.I.C. n. 044077016 (in base 10) 1B13YS (in base 32). Confezione: «1 mg/10 ml (1:10.000) soluzione iniettabile in siringa preriempita» 10 siringhe preriempite in PP senza ago - A.I.C. n. 044077028 (in base 10) 1B13Z4 (in base 32). Forma farmaceutica: soluzione iniettabile in siringa preriempita. Composizione: principio attivo: ogni ml di soluzione iniettabile contiene 0,1 mg di adrenalina (come adrenalina tartrato);
ogni siringa preriempita da 10 ml contiene 1 mg di adrenalina (come adrenalina tartrato). Eccipienti: sodio cloruro;
acido cloridrico (per l'aggiustamento del pH);
sodio idrossido (per l'aggiustamento del pH);
acqua per preparazioni iniettabili. Produzione del principio attivo: Boehringer Ingelheim Pharma Gmbh &
CO. Kg. Binger Strasse 173 - 55216 Ingelheim Am Rhein - Germania. Cambrex Profarmaco Milano S.R.L. - Via Curiel, 34 - 20067 Paullo, Milano - Italia. Produzione, controllo di qualita', rilascio dei lotti, confezionamento primario e secondario. Laboratoire Aguettant 1, rue Alexander Fleming - 69007 Lyon - Francia. Indicazioni terapeutiche: rianimazione cardiopolmonare;
anafilassi acuta negli adulti. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della...
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