DETERMINAZIONE 28 aprile 2008 - Modifica del provvedimento 26 agosto 1999, concernente l''inserimento del medicinale «Trientine diidrocloridrato», nell''elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale.
Visto il provvedimento 26 agosto 1999 della Commissione unica del farmaco concernente l'inserimento del medicinale ´trientine diidrocloridratoª nell'elenco dei medicinali erogabili a totale carico del Servizio sanitario nazionale ai sensi dell'art. 1, comma 4, del decreto-legge 21 ottobre 1996, n. 536, convertito dalla legge 23 dicembre 1996, n. 648, nel trattamento del morbo di Wilson in pazienti intolleranti alla D-penicillamina;
Atteso che, con determinazione AIFA del 5 agosto 2005, pubblicata nella Gazzetta Ufficiale n. 196 del 24 agosto 2005, e' stata autorizzata all'immissione in commercio ed e' regolarmente in vendita sul territorio nazionale la specialita' medicinale Wilzin (zinco acetato diidrato), specificatamente indicata per il trattamento del morbo di Wilson e registrata per questa indicazione con procedura centralizzata europea;
Considerato che l'indicazione terapeutica per la quale il trientine diidrocloridrato e' stato inserito nell'elenco di cui alla legge n. 648/1996 (agosto 1999) e': Morbo di Wilson in pazienti intolleranti alla D-penicillamina;
Atteso che il medicinale trientine diidrocloridrato, anche in virtu' della particolare enunciazione ´mirataª dell'indicazione, puo' tuttora costituire una valida alternativa terapeutica nel trattamento del Morbo di Wilson per i pazienti non candidabili o non rispondenti ai trattamenti ora disponibili sul mercato;
Ritenuto opportuno continuare a consentire a soggetti affetti da tale patologia la prescrizione di detto medicinale a totale carico del Servizio sanitario nazionale;
Ritenuto di dover...
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