Mulpleo (previously Lusutrombopag Shionogi)

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Withdrawn

This medicine's authorisation has been withdrawn

lusutrombopag
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

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. 

Mulpleo : EPAR - Medicine overview

Reference Number: EMA/553072/2019

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български (BG) (125.14 KB - PDF)

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español (ES) (93.83 KB - PDF)

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čeština (CS) (118.08 KB - PDF)

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Deutsch (DE) (94.28 KB - PDF)

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eesti (ET) (91.84 KB - PDF)

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ελληνικά (EL) (131.96 KB - PDF)

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français (FR) (94.17 KB - PDF)

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hrvatski (HR) (113.83 KB - PDF)

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italiano (IT) (92.96 KB - PDF)

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latviešu (LV) (119.27 KB - PDF)

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lietuvių (LT) (117.04 KB - PDF)

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magyar (HU) (114.35 KB - PDF)

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Malti (MT) (119.17 KB - PDF)

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Nederlands (NL) (93.17 KB - PDF)

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polski (PL) (118.96 KB - PDF)

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português (PT) (93.93 KB - PDF)

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română (RO) (115.36 KB - PDF)

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slovenčina (SK) (117.92 KB - PDF)

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slovenščina (SL) (110.76 KB - PDF)

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suomi (FI) (93.07 KB - PDF)

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svenska (SV) (93.52 KB - PDF)

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Lusutrombopag Shionogi : EPAR - Risk-management-plan summary

English (EN) (83.73 KB - PDF)

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Product information

Mulpleo : EPAR - Product information

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български (BG) (767.08 KB - PDF)

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español (ES) (682.37 KB - PDF)

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čeština (CS) (725.37 KB - PDF)

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dansk (DA) (639.12 KB - PDF)

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Deutsch (DE) (693.11 KB - PDF)

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eesti (ET) (660.71 KB - PDF)

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ελληνικά (EL) (713.97 KB - PDF)

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français (FR) (695.99 KB - PDF)

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hrvatski (HR) (706.82 KB - PDF)

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italiano (IT) (699.99 KB - PDF)

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latviešu (LV) (744.83 KB - PDF)

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lietuvių (LT) (700.32 KB - PDF)

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magyar (HU) (699.68 KB - PDF)

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Malti (MT) (677.5 KB - PDF)

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Nederlands (NL) (680.76 KB - PDF)

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polski (PL) (689.68 KB - PDF)

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português (PT) (697.96 KB - PDF)

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română (RO) (714.59 KB - PDF)

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slovenčina (SK) (731.15 KB - PDF)

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slovenščina (SL) (701.94 KB - PDF)

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suomi (FI) (669.65 KB - PDF)

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svenska (SV) (668.05 KB - PDF)

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Íslenska (IS) (699.11 KB - PDF)

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norsk (NO) (632.41 KB - PDF)

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Latest procedure affecting product information:IAIN/0017/G
05/01/2024
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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:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Mulpleo (previously Lusutrombopag Shionogi) : EPAR - All authorised presentations

English (EN) (26.9 KB - PDF)

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български (BG) (84.68 KB - PDF)

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español (ES) (42.61 KB - PDF)

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čeština (CS) (60.17 KB - PDF)

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dansk (DA) (42.46 KB - PDF)

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Deutsch (DE) (42.26 KB - PDF)

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eesti (ET) (42.65 KB - PDF)

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ελληνικά (EL) (85.14 KB - PDF)

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français (FR) (42.38 KB - PDF)

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hrvatski (HR) (59.11 KB - PDF)

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italiano (IT) (42.1 KB - PDF)

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latviešu (LV) (79.8 KB - PDF)

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lietuvių (LT) (80.11 KB - PDF)

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magyar (HU) (80.66 KB - PDF)

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Malti (MT) (79.63 KB - PDF)

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Nederlands (NL) (41.79 KB - PDF)

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polski (PL) (60.12 KB - PDF)

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português (PT) (43.18 KB - PDF)

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română (RO) (79.18 KB - PDF)

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slovenčina (SK) (60.58 KB - PDF)

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slovenščina (SL) (59.25 KB - PDF)

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suomi (FI) (42.34 KB - PDF)

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svenska (SV) (42.39 KB - PDF)

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Íslenska (IS) (42.49 KB - PDF)

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norsk (NO) (42.05 KB - PDF)

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Product details

Name of medicine
Mulpleo (previously Lusutrombopag Shionogi)
Active substance
Lusutrombopag
International non-proprietary name (INN) or common name
lusutrombopag
Therapeutic area (MeSH)
Thrombocytopenia
Anatomical therapeutic chemical (ATC) code
B02BX

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures

Authorisation details

EMA product number
EMEA/H/C/004720
Marketing authorisation holder
Shionogi B.V.

Herengracht 464
1017 CA
Amsterdam
The Netherlands

Opinion adopted
13/12/2018
Marketing authorisation issued
18/02/2019
Withdrawal of marketing authorisation
14/04/2026
Revision
9

Assessment history

Mulpleo : Procedural steps taken and scientific information after authorisation

English (EN) (172.77 KB - PDF)

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Lusutrombopag Shionogi : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/817852/2018

English (EN) (5.4 MB - PDF)

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CHMP summary of positive opinion for Lusutrombopag Shionogi

Adopted Reference Number: EMA/CHMP/862586/2018

English (EN) (120.75 KB - PDF)

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