COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Rocuronio Hikma». (15A04177)
Estratto determina n. 641/2015 del 20 maggio 2015 Medicinale: ROCURONIO HIKMA Titolare AIC: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mo', n.8, 8A, 8B, Fervença 2705-906 Terrugem SNT Portogallo Confezione 10 mg/ml, soluzione iniettabile o per infusione. 10 flaconcini in vetro da 50 mg/5 ml - AIC n. 042577015 (in base 10) 18MC3R (in base 32) Forma farmaceutica: Soluzione iniettabile/ infusione. Composizione: Ogni ml di Rocuronio Hikma contiene: Principio attivo: 10 mg di rocuronio bromuro. Ogni flaconcino da 5ml contiene 50 mg di rocuronio bromuro. Eccipienti: Rocuronio Hikma contiene i seguenti eccipienti: Sodio acetato triidrato Sodio cloruro Sodio idrossido (per la regolazione del pH) Acido acetico (per la regolazione del pH) Acqua per preparazioni iniettabili Produzione principio attivo: Rocuronio bromuro Aspen Oss B.V. Kloosterstaat, 5 5349 AB Oss (a.k.a. Moleneind) Paesi Bassi (produzione, controllo analitico, confezionamento, conservazione, controllo qualita' e rilascio dei lotti del principio attivo) Rocuronio bromuro Aspen Oss B.V. Veersemeer 4, 5347 JN Oss (a.k.a. Diosite) Paesi Bassi (produzione, controllo analitico, confezionamento, conservazione, controllo qualita' e rilascio dei lotti del principio attivo) Produzione, riempimento, controllo analitico, confezionamento primario e secondario, controllo qualita' e rilascio dei lotti: Hikma Farmacêutica (Portugal) S.A. Estrada do Rio da Mo', 8, 8A, 8B. Fervença, 2705-906 Terrugem SNT Portugal Indicazioni terapeutiche: Rocuronio Hikma e' indicato negli adulti e nei pazienti pediatrici (dai neonati a termine agli adolescenti da 0 a meno di 18 anni), in aggiunta all'anestesia generale, per facilitare l'intubazione tracheale durante l'induzione standard e per ottenere il rilassamento della muscolatura scheletrica durante l'intervento chirurgico. Negli...
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