COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Kovilen» (18A06033)
Estratto determina AAM/PPA n. 747 del 3 settembre 2018 Autorizzazione della variazione: Variazione grouping di tipo B.II.b.2.c.2), B.II.f.1.a.1), B.II.b.4.d), B.II.b.5.c), B.II.b.1.a), B.II.b.5.z), B.II.b.2.a), B.II.b.3.a), relativamente al medicinale KOVILEN;
Codice pratica: VN2/2016/355. Sono autorizzate le seguenti variazioni: modifica nuovo fornitore del materiale di confezionamento primario;
modifica flacone;
modifica materiali del confezionamento primario per il nuovo fornitore;
modifiche delle specifiche del flacone, del tappo e del contagocce per il nuovo fornitore;
aggiunta di un sito come responsabile della sterilizzazione dell'ossido di etilene del materiale del confezionamento primario del nuovo fornitore. Titolare A.I.C.: Mediolanum Farmaceutici S.p.a. (codice fiscale 01689550158) con sede legale e domicilio fiscale in via San G. Cottolengo, 15 -...
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