COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Apelka 5 mg/ml» soluzione orale per gatti. (18A08199)
Estratto provvedimento n. 870 del 29 novembre 2018 Medicinale veterinario: APELKA 5 mg/ml soluzione orale per gatti. Confezioni: A.I.C. n. 104880. Titolare dell'A.I.C.: Norbrook Laboratories Limited, Station Works, Newry, Co. Down, BT35 6JP - Regno Unito. Oggetto del provvedimento: numero procedura europea: UK/V/0565/001/IA/001. Si conferma la modifica come di seguito riportata: Variazione C.II.6.a - Eliminazione del rappresentante locale del titolare dell'autorizzazione all'immissione in commercio di seguito riportato: Boehringer Ingelheim Italia S.p.A. - via Giovanni Lorenzini n. 8 - 20139 Milano. Per effetto della suddetta variazione gli stampati devono essere modificati come segue: informazioni da apporre sull'imballaggio esterno: Punto 15. Nome e indirizzo del titolare dell'autorizzazione all'immissione in commercio e fabbricante responsabile del rilascio dei lotti di fabbricazione, se diversi. Titolare dell'autorizzazione all'immissione in commercio e produttore responsabile del...
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