Mulpleo (previously Lusutrombopag Shionogi)

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lusutrombopag

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 08/03/2023

Authorisation details

Product details
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 monitoringAdditional 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
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
1017 CA
Amsterdam
The Netherlands

Product information

07/03/2023 Mulpleo (previously Lusutrombopag Shionogi) - EMEA/H/C/004720 - IAIN/0017/G

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Product information documents contain:

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

Assessment history

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