COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Clearverm» (14A06263)
Estratto del provvedimento n. 576 del 10 luglio 2014 Medicinale veterinario CLEARVERM (A.I.C. n. 103986). Confezioni: 016 scatola da 2 compresse;
028 scatola da 6 compresse;
030 scatola da 24 compresse;
042 scatola da 104 compresse. Titolare A.I.C.: Bayer S.p.a., con sede legale e domicilio fiscale in Milano, viale Certosa n. 130 - codice fiscale n. 05849130157. Modifica: Variazione di tipo IA: B.II.e.1 Modifica del confezionamento primario del prodotto finito;
composizione qualitativa e quantitativa di forme farmaceutiche solide: aggiunta di un nuovo contenitore. Per effetto della suddetta variazione il punto 6.5 del «Riassunto delle caratteristiche del prodotto» (RCP) del medicinale in questione deve essere modificato come segue: «6.5 Natura e composizione del confezionamento primario. Blister in laminato di alluminio con uno smalto per saldatura a caldo. Oppure: Blister costituito da un foglio in PA/Al/HDPE saldato con un foglio in...
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