COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Tobraluxcort» (16A02944)
Estratto determina n. 475 /2016 del 31 marzo 2016 Medicinale: TOBRALUXCORT. Titolare A.I.C.: Sooft Italia Srl Contrada Molino 17 - 63833 Montegiorio (FM). Confezione: «3mg/ml + 1mg/ml collirio, soluzione» 1 flacone in LDPE da 5 ml - A.I.C. n. 041909019 (in base 10) 17YYSV (in base 32). Forma farmaceutica: collirio, soluzione. Composizione: ogni ml di soluzione contiene: principio attivo: 3 mg di tobramicina e 1,30 mg di desametasone sodio fosfato equivalente a 1 mg di desametasone;
eccipienti: benzalconio cloruro;
tyloxapol;
cloruro di sodio;
solfato di sodio, anidro;
acido borico;
acqua per iniezioni;
acido solforico e/o idrossido di sodio come correttore di pH. Produzione principio attivo: dexametasone: Symbiotica Speciality Ingredients Sdn Bhd - 517&518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah Darul Aman-Malaysia;
tobramicina: Teva Pharmaceutical Works Private Limited Company_4042 Debrecen, Pallagi ut 13-Hungary. Rilascio lotti: Novocat Farma S.A._Avda de La Flores, 29, Rubi', 08191 Barcelona-Spain. Confezionamento primario e secondario: Unimed Laboratories Industrial Zone Kalaa Kebira, Sousse - 4060 Tunisia. Indicazioni terapeutiche: controllo della sintomatologia infiammatoria e profilassi delle infezioni secondarie dopo interventi di chirurgia oculare. Da somministrare sotto stretta sorveglianza dell'oculista. Quando si prescrive «Tobraluxcort» bisogna tenere in considerazione l'importanza disporre di una guida all'uso appropriato di agenti antibatterici. Classificazione ai fini della rimborsabilita' Confezione: «3 mg/ml + 1mg/ml collirio, soluzione» 1 flacone in LDPE da 5 ml - A.I.C. n...
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