COMUNICATO - Rettifica della determina AAM/PPA n. 528/2020 del 21 settembre 2020, concernente la modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Celluvisc». (20A06244)
Estratto determina AAM/PPA n. 607/2020 del 14 ottobre 2020
La determina AAM/PPA n. 528/2020 del 21 settembre 2020, relativa alla specialita' medicinale CELLUVISC, pubblicata nella Gazzetta Ufficiale, Serie generale n. 244 del 2 ottobre 2020, e' rettificata mediante la sostituzione del seguente paragrafo:
ove si legge:
Smaltimento scorte
Sia i lotti gia' prodotti alla data di pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determina che i lotti prodotti nel periodo di cui all'art. 2, comma 1, della presente determina, che non riportino le modifiche autorizzate, possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta. A decorrere dal termine di trenta giorni dalla data di pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determina, i farmacisti sono tenuti a consegnare il foglio illustrativo aggiornato agli utenti, che scelgono la modalita' di ritiro in formato cartaceo o analogico o mediante l'utilizzo di metodi digitali alternativi. Il titolare A.I.C. rende accessibile al farmacista il foglio illustrativo aggiornato entro il medesimo termine.
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...Smaltimento scorte
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