COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Brimonidina JGL». (15A02797)
Estratto determina n. 362/2015 del 30 marzo 2015 Medicinale: BRIMONIDINA JGL. Titolare A.I.C.: Jadran-Galenski LAboratorij, d.o.o Ljubljana - Litostrojska cesta 46A - 1000 Ljubljana - Slovenia. Confezione: «2 mg/ml collirio, soluzione» 1 flacone in LDPE da 5 ml - A.I.C. n. 043487014 (in base 10), 19H3T6 (in base 32). Forma farmaceutica: collirio, soluzione. Composizione: 1 ml di soluzione contiene: principio attivo: 2 mg di brimonidina tartrato, equivalente a 1,3 mg di brimonidina;
eccipienti: benzalconio cloruro, alcool polivinilico, sodio citrato, acido citrico monoidrato, sodio cloruro, acqua purificata, acido cloridrico (per l'aggiustamento del pH), idrossido di sodio (per l'aggiustamento del pH). Produzione del principio attivo: brimonidina tartrato: Indoco Remedies Ltd. (Kilo Lab), R-92/93, TTC, MIDC, Thane Belapur Road, Rabale, Navi Mumbai, 400 701 - India (produzione, controllo e rilascio lotti);
FDC Limited, Plot No. 19 &
20/2, M.I.D.C. Industrial Area, Village Dhatav, Roha, Dist. Raigad, Maharashtra State, 402 116 - India (produzione, controllo e rilascio lotti). Produzione, confezionamento primario e secondario, controllo lotti: Jadran-Galenski laboratorij d.d., Svilno 20, Rijeka, 51000 - Croazia. Rilascio lotti, controllo microbiologico dei lotti: Jadran-Galenski laboratorij d.d., Pulac 4A, Rijeka, 51000 - Croazia. Sterilizzazione del contenitore primario: Synergy Health Däniken AG, Hogenweidstrasse 6, Däniken, 4658 - Svizzera. Indicazioni terapeutiche: «Brimonidina JGL» e' indicato per la riduzione della pressione intraoculare (PIO) elevata nei pazienti con glaucoma ad angolo aperto o ipertensione oculare. Come monoterapia nei pazienti per i quali la terapia topica con betabloccanti e' controindicata. Come terapia aggiuntiva ad altri farmaci che abbassano la pressione intraoculare quando la PIO desiderata non viene raggiunta con un singolo agente. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12...
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