Retrieved determines the 2547/2014 December 2, 2014 n V & Authorize the change relatively to the medicine VIVOTIF.
Are authorized the following variation: B 2 c changes in the manufacturing process of the active substance. The change relates to a biological/immunological substance or use of a substance derived chemically different in the manufacture of a biological/immunological medicinal product and it's connected to a Protocol, relative to medicine, shapes and packages and Vivotif A.I.C.: A.I.C. # 025219041-"2,000 million gastro-resistant capsules, hard" blister 3 capsules;
A.I.C. # 025219054-"2,000 million capsules gastroresitenti" 50 blisters of 3 capsules;
A.I.C. # 025219066-"2,000 million gastro-resistant capsules, hard" 4 blister 1 capsule: the renewal of Vivotif vaccine production line B.
A.I.C. holder: Crucell Italy S.r.l. with registered office and tax domicile in via Zambeletti # 25-20021 Baranzate-Milano (MI)-Italy; tax ID # 00190430132.
Inventory disposal the batches produced commercially can be maintained until the expiry date of the medicine indicated on the label.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.