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) (updated)
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.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
18/02/2019
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Contact address |
Product information
30/08/2019 Mulpleo (previously Lusutrombopag Shionogi) - EMEA/H/C/004720 - N/00003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures