ヒト用医薬品欧州公開評価報告書（EPAR）：ムルプレオ（旧ルストロンボパグ塩野義製薬）、ルストロンボパグ、承認日：2019年2月18日、改訂：9、ステータス：取り下げ

記事本文

On 14 April 2026, the European Commission withdrew the marketing authorisation for Mulpleo (lusutrombopag) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Shionogi B. V. , which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Mulpleo was granted marketing authorisation in the EU on 18 February 2019 to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023. News on Mulpleo (previously Lusutrombopag Shionogi) Application under evaluation European Commission decision Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures This medicine's authorisation has been withdrawn This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need. Product information documents contain: English (EN) (95.09 KB – PDF) English (EN) (83.73 KB – PDF) English (EN) (648.96 KB – PDF) summary of product characteristics (annex I);

manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB);

package leaflet (annex IIIB). English (EN) (26.9 KB – PDF) Herengracht 4641017 CAAmsterdamThe Netherlands Mulpleo: EPAR – Medicine overview Lusutrombopag Shionogi: EPAR – Risk-management-plan summary Mulpleo: EPAR – Product information Mulpleo (previously Lusutrombopag Shionogi): EPAR – All authorised presentations български (BG) (125.14 KB – PDF) español (ES) (93.83 KB – PDF) čeština (CS) (118.08 KB – PDF) Deutsch (DE) (94.28 KB – PDF) ελληνικά (EL) (131.96 KB – PDF) français (FR) (94.17 KB – PDF) hrvatski (HR) (113.83 KB – PDF) italiano (IT) (92.96 KB – PDF) latviešu (LV) (119.27 KB – PDF) lietuvių (LT) (117.04 KB – PDF)