COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso veterinario «Modulis 100 mg/ml» soluzione orale per cani e «Adaxio 20mg/ml + 20 mg/ml» shampoo per cani. (17A01502)
Estratto provvedimento n. 883 dell'11 gennaio 2017 Numero procedura europea: UK/V/XXXX/IA/115/G Medicinali veterinari: MODULIS 100 mg/ml soluzione orale per cani (A.I.C 104707) ADAXIO 20 mg/ml + 20 mg/ml Shampoo per cani (A.I.C 104684) Confezioni: tutte. Titolare A.I.C: Ceva Salute Animale S.p.a. viale Colleoni 15 20864 Agrate Brianza (MB) - Italia Oggetto del provvedimento: numero procedura europea: UK/V/XXXX/IA/115/G Si accetta la modifica come di seguito descritta: variazione A.5 a) - A.5 modifica dell'indirizzo del fabbricante responsabile per il rilascio dei lotti di produzione. Da: Sogeval, 200 Avenue de Mayenne, Zone Industrielle Des Touches, 53000 Laval - France A: Ceva Sante Animale, 200 Avenue De Mayenne, Zone Industrielle Des Touches, 53000 Laval - France Altri siti attualmente autorizzati per il rilascio dei lotti di produzione: per il medicinale veterinario Modulis 100 mg/ml soluzione orale per cani: Laboratoires Biove, 3 Rue De Lorraine, 62510 Arques - France per il medicinale veterinario Adaxio 20 mg/ml + 20 mg/ml Shampoo per cani: Thepenier Pharma Industrie, Route D'Alencon, 61400 St. Langis Les Mortagne - France Per effetto della suddetta variazione gli stampati devono essere modificati come segue: per il medicinale veterinario Adaxio 20 mg/ml + 20 mg/ml Shampoo per cani: punto 1 del foglietto illustrativo, etichetta/foglietto illustrativo (per flacone senza imballaggio esterno) punto 15 informazioni da apporre sul confezionamento primario etichetta 1 flacone da 200 ml...
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