COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Rilexine 200 T» (19A01193)
Estratto provvedimento n. 66 del 31 gennaio 2019 Medicinale veterinario: RILEXINE 200 T. Confezioni: A.I.C. n. 101944. Titolare A.I.C.: VIRBAC S.A. - 1ere Avenue - 2065 m - L.I.D. - 06516 Carros - Francia. Oggetto del provvedimento: domanda di variazione raggruppata: 1 di tipo IB, B.II.a.3.b.6.z;
1 di tipo IB, B.II.b.3.a.z;
1 di tipo IB by default, B.II.d.1.z. Si accettano le modifiche di seguito descritte: l'eccipiente «olio di semi di soia» viene sostituito con l'eccipiente «olio di arachidi»;
viene eliminato il conservante alcool benzilico;
l'aspetto della sospensione viene descritto nel seguente modo «sospensione di colore da beige a giallo chiaro». Per effetto delle suddette variazioni si modificano le sezioni 2, 3 e 6.1 del riassunto delle...
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