The ruling published by AIFA in the Official Journal, on 23rd June 2014
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With the publication in the Official Journal no. 143 on 23rd June 2014, AIFA, the Italian Medicines Agency, officially approved the extension of the therapeutic indication of the polyvalent immunoglobulin manufactured by Kedrion for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). In addition, IG Vena and Venital, the products intended for the commercial market and for the Italian program for self-sufficiency in plasma-derivatives, become the first immunoglobulin products distributed in Italy to earn such indication with class H listing in the reimbursement program.<\/p>\n
This will ensure that patients all over Italy will receive equal treatments and will extend the range of indications for the products involved in the self-sufficiency program that Kedrion supports in partnership with the Italian National Blood Centre (CNS), the regional coordinators and the donors’ association and federations (Avis, Fidas, Fratres, Italian Red Cross).<\/p>\n
In Europe, IG Vena had already earned approval for the treatment of CIDP in Austria, Germany, Greece, Poland and Portugal in 2013 through mutual-recognition procedures.<\/p>\n
CIDP is a chronic, debilitating, autoimmune disorder of the peripheral nerves, resulting in a gradually increasing weakness of the legs and, to a lesser extent, of the arms. Such disease can occur at any age and in both genders, and its incidence is approximately 4 per 100.000 in the population. For several years now, Kedrion has been a sound partner of associations, such as the Peripheral Nerve Society (PNS), the European Academy of Neurology (EAN) and the Associazione italiana per lo studio del Sistema Nervoso Periferico (ASNP, the Italian Association for the study of the peripheral nervous system), which work on an international scale to improve patients’ access to treatments for neurological disorders.<\/p>\n","protected":false},"featured_media":0,"template":"","categories_news":[46],"class_list":["post-3759","news","type-news","status-publish","hentry","categories_news-plasma-biotherapies-en-us"],"acf":[],"yoast_head":"\n