COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Remifenfanil Pfizer» (13A02578)
Estratto determinazione n. 303 del 15 marzo 2013 Medicinale: REMIFENFANIL PFIZER. Titolare AIC: Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Confezione «1 mg polvere per concentrato per soluzione iniettabile o per infusione» 5 flaconcini in vetro AIC n. 042034013/M (in base 10) 182SUX (in base 32) Confezione «2 mg polvere per concentrato per soluzione iniettabile o per infusione» 5 flaconcini in vetro AIC n. 042034025/M (in base 10) 182SV9 (in base 32) Confezione «5 mg polvere per concentrato per soluzione iniettabile o per infusione» 5 flaconcini in vetro AIC n. 042034037/M (in base 10) 182SVP (in base 32) Forma farmaceutica: polvere per concentrato per soluzione iniettabile o per infusione. Composizione: ogni flaconcino contiene: Principio attivo: remifentanil cloridrato equivalente a 1 mg di remifentanil remifentanil cloridrato equivalente a 2 mg di remifentanil remifentanil cloridrato equivalente a 5 mg di remifentanil Ogni ml di Remifentanil Pfizer 1 mg/2 mg/5 mg, polvere per concentrato per soluzione iniettabile o per infusione contiene 1 mg di remifentanil quando ricostituito secondo le istruzioni. Eccipienti: Glicina Acido cloridrico (per aggiustare il pH) Produzione, confezionamento, controllo, rilascio: IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Roßlau Germania Confezionamento, controllo, rilascio: Hameln pharmaceuticals GmbH Langes Feld 13, 31789 Hameln Germania Produzione, confezionamento: Hemofarm A.D. Beogradski put bb, 26300 Vršac Serbia Produzione principio attivo: Fine Chemicals Corporation (Pty) Limited 15 Hawkins Avenue, Epping 1, 7460 Cape Town Sud Africa Indicazioni terapeutiche: Remifentanil e' indicato come agente analgesico per l'uso...
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