COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Intraseal 2,6 g sospensione intramammaria per bovini». (18A07806)
Estratto provvedimento n. 820 del 7 novembre 2018 Medicinale veterinario Intraseal 2,6 g sospensione intramammaria per bovini (A.I.C. n. 104549). Titolare A.I.C.: Norbrook Laboratories Limited, Station Works, Camlough Road Newry, Co. Down BT35 6JP Irlanda del nord. Oggetto del provvedimento: procedura europea n. UK/V/0473/001/IB/012. Si autorizzano, per il medicinale veterinario indicato in oggetto, le modifiche dei PIL (etichetta esterna, etichetta interna e foglietto illustrativo) conformemente a quanto autorizzato con la chiusura di rinnovo UK/V/0473/001/R/001. La variazione sopra indicata modifica i seguenti punti del foglietto illustrativo ed i corrispondenti paragrafi delle etichette: foglietto illustrativo: 1. Nome ed indirizzo del titolare dell'autorizzazione all'immissione in commercio e del titolare dell'autorizzazione alla produzione responsabile del rilascio dei lotti di fabbricazione, se diversi: titolare dell'autorizzazione all'immissione in commercio: Norbrook Laboratories Limited, Station Works, Newry, Co. Down, Irlanda del Nord - BT35 6JP;
produttore responsabile del rilascio dei lotti: Norbrook Laboratories Limited 105 Armagh Road, Newry, Co. Down, Irlanda del Nord - BT35 6PU;
Norbrook Laboratories Limited, Station Works, Newry, Co. Down, Irlanda del Nord - BT35 6JP;
Distribuito da: Bayer S.p.A. viale Certosa n. 130 - 20156 Milano. 2. Denominazione del medicinale veterinario: Intraseal 2,6 g sospensione intramammaria...
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