Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale .
Estratto provvedimento n. UPC/R/42 del 9 agosto 2006
Specialita' medicinale: OMNIC.
Confezioni:
032647012/M - ´0,4 mg capsule rigide a rilascio modificatoª 30 capsule in blister PP/AL;
032647024/M - ´0,4 mg capsule rigide a rilascio modificatoª 20 capsule in blister PP/AL.
Titolare A.I.C.: Astellas Pharma S.p.a.
Numero procedura mutuo riconoscimento: NL/H/105/01/R/02.
Tipo di modifica: a seguito di una rivalutazione del profilo di sicurezza del medicinale condotta durante la procedura di rinnovo, e' emersa la necessita' di modificare il riassunto delle caratteristiche del prodotto alle sezioni 4.4 e 4.8; indicando una riconosciuta complicanza osservata durante l'intervento chirurgico di faco-emulsificazione della cataratta in alcuni pazienti in corso di trattamento o in precedenza trattati con tamsulosina, recentemente definita ´Sindrome dell'iride a bandieraª.
Tipo autorizzazione: modifica stampati a seguito di rinnovo dell'autorizzazione all'immissione in commercio secondo procedura di mutuo riconoscimento.
In conformita' all'allegato che costituisce parte integrante del presente provvedimento il titolare dell'autorizzazione all'immissione in commercio deve apportare le necessarie modifiche al riassunto delle caratteristiche del...
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