COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Alphagan» (18A00833)
Estratto determina IP n. 6 dell'8 gennaio 2018 E' autorizzata l'importazione parallela del medicinale ALPHAGAN 2 mg/ml colirio en solucion 1 frasco de 5 ml dalla Spagna con numero di autorizzazione 62010 C.N. 653734-3 il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: GMM Farma S.r.l. con sede operativa presso Cis di Nola - Isola 8, Lotto 8100, 80035 Nola (Napoli) e sede amministrativa presso via Lambretta 2, 20090 Segrate (MI) Confezione: ALPHAGAN 1 flacone da 5 ml di collirio soluzione. Codice AIC: 045633017 (in base 10) 1CJMHT (in base 32). Forma farmaceutica: collirio, soluzione. Composizione: 1 ml di soluzione contiene: principio attivo: 2,0 mg di brimonidina tartrato, equivalente a 1,3 mg di brimonidina. eccipienti: benzalconio cloruro, alcool polivinilico, sodio cloruro, sodio citrato, acido citrico monoidrato, acqua depurata, acido cloridrico o sodio idrossido. Indicazioni terapeutiche: riduzione della pressione intraoculare (PIO) elevata in pazienti con glaucoma ad angolo aperto o ipertensione oculare. come monoterapia in pazienti per i quali e' controindicata una terapia topica con beta-bloccanti. come terapia aggiuntiva ad altri farmaci che abbassano la pressione intraoculare quando l'obiettivo PIO non e' raggiunto con un singolo principio attivo Officine di...
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