Eisai Receives Approval for Partial Label Change for Vascular Embolization Device DC Bead
Product name：Eisai Receives Approval for
TOKYO, Sep 3, 2018 - (JCN Newswire) - Eisai Co., Ltd. announced that it has received approval for a partial label change for the vascular embolization device DC Bead (specially controlled medical device) in Japan. The product is to be used for transcatheter arterial embolization in patients with hypervascular tumors (excluding uterine fibroids).
In real-world clinical settings, it was found that DC Bead was not being used in the treatment of uterine fibroids and arteriovenous malformations. Following confirmation at related academic associations and subsequent consultation with the regulatory authority, an application for a partial label change for the relevant indication was submitted, upon which this approval is based.
With the partial label change for DC Bead, Eisai is striving to ensure that accurate information is provided to healthcare professionals.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of Aricept, a treatment for Alzheimer's disease and dementia with Lewy bodies, Eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. As a pioneer in the field of dementia treatment, Eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
Public Relations Department,
Eisai Co., Ltd.
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Eisai Receives Approval for