COMUNICATO - Modifica della determina n. 1364/2016 del 29 settembre 2016, concernente l'autorizzazione all'immissione in commercio del medicinale per uso umano «Abacavir e Lamivudina EG». (18A08096)
Estratto determina n. 1890/2018 del 27 novembre 2018 Medicinale: ABACAVIR E LAMIVUDINA EG. Titolare A.I.C.: EG S.p.A. - via Pavia 6 - 20136 Milano. E' modificata, nei termini che seguono, la determina n. 1364 del 29 settembre 2016, concernente l'autorizzazione all'immissione in commercio del medicinale «Abacavir e Lamivudina EG», il cui estratto e' stato pubblicato nella Gazzetta Ufficiale del n. 252 del 27 ottobre 2016: Si intenda eliminato: Qualora il principio attivo, sia in monocomponente che in associazione, sia sottoposto a copertura brevettuale o al certificato di protezione complementare, la classificazione di cui alla presente determinazione ha efficacia, ai sensi dell'art. 11, comma 1, ultimo periodo, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, dal giorno successivo alla data di scadenza del brevetto o del certificato di protezione complementare, pubblicata dal Ministero dello sviluppo...
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