COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale veterinario 'FIPROLINE' 50 mg Soluzione spot-on per gatti. (13A00118)
Provvedimento n. 1069 del 18 dicembre 2012 Procedura di Mutuo Riconoscimento n. UK/V/xxxx/IA/032/G Medicinale veterinario «FIPROLINE» 50 mg Soluzione spot-on per gatti Confezioni: scatola da 1 pipetta A.I.C. n. 104067018 scatola da 2 pipette A.I.C. n. 104067020 scatola da 3 pipette A.I.C. n. 104067032 scatola da 4 pipette A.I.C. n. 104067044 scatola da 6 pipette A.I.C. n. 104067057 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 il 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 bianche monodose o trasparenti in plastica multistrato contenenti un volume estraibile di 0,5 ml. Lo strato interno a contatto...
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