エーザイ、中心循環系血管内塞栓促進用補綴材「ディーシービーズ」使用目的又は効果の一部削除の承認について

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2018年09月03日 16時00分

Source: Eisai

エーザイ、中心循環系血管内塞栓促進用補綴材「ディーシービーズ」使用目的又は効果の一部削除の承認について

東京, 2018年09月03日 - (JCN Newswire) - エーザイ株式会社（本社：東京都、代表執行役CEO：内藤晴夫）は、このたび、日本において、中心循環系血管内塞栓促進用補綴材「ディーシービーズ(R)」（高度管理医療機器、以下本品）について、使用目的又は効果の一部削除が承認され、使用目的又は効果が「多血性腫瘍（子宮筋腫を除く）を有する患者に対する動脈塞栓療法」となりましたことをお知らせします。

今回の使用目的又は効果の一部削除の承認は、実臨床上、本品は「子宮筋腫」及び「動静脈奇形」に対して使用されないことから、関連学会に確認の上、当局と相談し、当該適応に係る使用目的又は効果の取り下げの一部変更承認申請を行っていたことに基づくものです。

当社は、本使用目的又は効果の一部削除に際し、医療関係者の皆様への適切な情報提供に努めてまいります。

本リリースの詳細は下記をご参照ください。
https://www.eisai.co.jp/news/2018/news201876.html

概要：エーザイ株式会社

詳細は www.eisai.co.jp をご覧ください。

Source: Eisai
セクター: バイオテック

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