Mulpleo (previously Lusutrombopag Shionogi)
lusutrombopag
Table of contents
Overview
Mulpleo is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.
The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body).
Mulpleo contains the active substance lusutrombopag.
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Mulpleo : EPAR - Medicine overview (PDF/74.75 KB)
First published: 14/03/2019
Last updated: 20/11/2019
EMA/553072/2019 -
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Lusutrombopag Shionogi : EPAR - Risk-management-plan summary (PDF/73.06 KB)
First published: 14/03/2019
Authorisation details
Product details | |
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Name |
Mulpleo (previously Lusutrombopag Shionogi)
|
Agency product number |
EMEA/H/C/004720
|
Active substance |
Lusutrombopag
|
International non-proprietary name (INN) or common name |
lusutrombopag
|
Therapeutic area (MeSH) |
Thrombocytopenia
|
Anatomical therapeutic chemical (ATC) code |
B02BX
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Shionogi B.V.
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
18/02/2019
|
Contact address |
Herengracht 464 |
Product information
07/03/2023 Mulpleo (previously Lusutrombopag Shionogi) - EMEA/H/C/004720 - IAIN/0017/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures