COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Misyo». (15A02799)
Estratto determina n. 348/2015 del 30 marzo 2015 Medicinale: MISYO. Titolare A.I.C.: INN-FARM d.o.o. - Maleševa ulica 014 - 1000 Ljubljana - Slovenia. Confezioni: «10 mg/ml concentrato per soluzione orale» 1 flacone in vetro da 100 ml - A.I.C. n. 042044014 (in base 10), 1832MG (in base 32);
10 mg/ml concentrato per soluzione orale
1 flacone in vetro da 1000 ml - A.I.C. n. 042044026 (in base 10), 1832MU (in base 32). Forma farmaceutica: concentrato per soluzione orale. Composizione: ogni ml di concentrato per soluzione orale contiene: principio attivo: 10 mg di metadone cloridrato;
eccipienti: sorbitolo liquido non cristallizzabile (E420), glicerolo (E422), sodio benzoato (E211), acido citrico monoidrato (E330), colorante blu brillante FCF (E133), acqua depurata. Produzione principio attivo: Siegfried Ltd. - Untere Brühlstrasse 4 - 4800 Zofingen - Svizzera;
Pioneer Agro Industries - Plot n.8, MIDC Industrial Estate, Post Kulgaon, Thane District, 421 503 Badlapur, Maharashtra - India. Rilascio lotti: Alkaloid-Int d.o.o. - Šlandrova ulica 4, 1231 Ljubljana-Črnuče - Slovenia. Controllo lotti: Hameln rds a.s. - Horna 36, 900 01 Modra - Slovacchia;
Marifarm, proizvodnja in storitve d.o.o. - Minarikova ulica 8, 2000 Maribor - Slovenia;
Marifarm contract, Zavod za zdravstveno varstvo Maribor - Prvomajska ulica 1, 2001 Maribor - Slovenia. Produzione, confezionamento primario e secondario: Alkaloid AD-Skopje - blvd. Aleksandar Makedonski 12, 1000 Skopje - Macedonia. Indicazioni terapeutiche: terapia di sostituzione di mantenimento per la dipendenza da oppiodi nell'adulto, unitamente ad adeguata assistenza medica, sociale e psico-sociale. 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...
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