COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale veterinario 'FIPROLINE' 67 mg, 134 mg, 268 mg e 402 mg soluzione spot-on per cani di taglia piccola, media, grande e gigante. (13A00119)
Provvedimento n. 1067 del 18 dicembre 2012 Medicinale veterinario FIPROLINE 67 mg, 134 mg, 268 mg e 402 mg Soluzione spot-on per cani di taglia piccola, media, grande e gigante . Procedura di mutuo riconoscimento n. UK/V/xxxx/IA/032/G Per tutte le confezioni: A.I.C. n. 104068. Titolare A.I.C.: Alfamed con sede in 13eme rue - L.I.D. - 06517 Carros Cedex (Francia). Oggetto del provvedimento: Variazione tipo IA: aggiunta di un blister individuale per ogni pipetta. Si autorizza, per tutte le confezioni del medicinale veterinario indicato in oggetto, l'aggiunta di un blister individuale per ogni pipetta, cosi' che la scatola del medicinale puo' contenere pipette con o senza il blister individuale per ogni pipetta. La modifica sopra indicata impatta sul punto 6.5 del SPC, come di seguito indicato: 6.5 Natura e composizione del condizionamento primario. Pipette termoformate: Pipette monodose bianche o trasparenti in plastica multistrato contenenti un volume estraibile di 0,67 ml (per cani di taglia piccola), 1,34 ml (per cani di taglia media), 2,68 ml (per cani di taglia grande), 4,02 ml (per cani di taglia gigante). Lo strato interno a contatto con il prodotto e' composto da...
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