DECRETO 3 settembre 2002 - Modificazione al decreto n. 370 del 22 luglio 2002 concernente "Medicinali la cui autorizzazione all'immissione in commercio non risulta rinnovata ai sensi dell'art. 11 del decreto legislativo 29 maggio 1991, n. 178, cosi' come modificato ed integrato dal decreto legislativo 18 febbraio 1997, n. 44"
IL DIRIGENTE del Dipartimento della tutela della salute umana, della sanita' pubblica veterinaria e dei rapporti internazionali - Direzione generale della valutazione dei medicinali e della farmacovigilanza - Ufficio autorizzazione all'immissione in commercio dei medicinali
Visto il decreto legislativo 29 maggio 1991, n. 178, con particolare riferimento agli articoli 2, 8 e 11, cosi' come modificato dal decreto legislativo del 18 febbraio 1997, n. 44; Visti i decreti legislativi 31 dicembre 1992, n. 539 e n. 540; Visto il decreto legislativo 3 febbraio 1993, n. 29, e successive modifiche ed integrazioni; Visto il decreto dirigenziale del 29 luglio 1997 con il quale e' stata affidata al dirigente medico dott.ssa Caterina Gualano la funzione di direttore dell'ufficio IV - Autorizzazioni all'immissione in commercio dei medicinali; Visto il decreto ministeriale, con il quale e' stata concessa l'autorizzazione all'immisione in commercio della specialita' medicinale Trusopt nella confezione "soluzione oftalmica 2% 5 ml in contenitore ocumeter plus" (A.I.C. n. 031848017), a favore della societa' Merck Sharp e Dohme (Italia) S.p.a.; Visto il decreto n. 370 del 22 luglio 2002 con il quale sono state revocate, per mancato rinnovo, le autorizzazioni all'immissione in commercio di alcuni medicinali, tra cui quella relativa al prodotto suddetto; Considerato che, da accertamenti eseguiti, per il medicinale di cui trattasi la domanda di rinnovo e' stata presentata nei termini...
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