COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Lisinopril e Idroclorotiazide Zentiva». (12A11538)
Estratto determinazione V & A 1387 del 21 settembre 2012
Specialita' medicinale: LISINOPRIL E IDROCLOROTIAZIDE ZENTIVA.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento.
Titolare A.I.C.: Zentiva Italia S.R.L.
Numero Procedura Mutuo Riconoscimento: DK/H/1292/001/II/014.
Tipo di modifica: Modifica o aggiunta di impressioni, rilievi o altre marcature compresa l'aggiunta o la modifica di inchiostri usati per marcare il medicinale: altra variazione.
Modifica apportata: Eliminazione del sovradosaggio di losinopril diidrato, pari circa al 2% ed...
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