Doptelet
avatrombopag
Table of contents
Overview
Doptelet 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).
Doptelet contains the active substance avatrombopag.
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Doptelet : EPAR - Medicine overview (PDF/104.1 KB)
First published: 25/06/2019
EMA/243810/2019 -
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Doptelet : EPAR - Risk-management-plan summary (PDF/293.18 KB)
First published: 25/06/2019
Last updated: 28/01/2021
Authorisation details
Product details | |
---|---|
Name |
Doptelet
|
Agency product number |
EMEA/H/C/004722
|
Active substance |
avatrombopag maleate
|
International non-proprietary name (INN) or common name |
avatrombopag
|
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 |
Swedish Orphan Biovitrum AB (publ)
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
20/06/2019
|
Contact address |
SE-112 76 Stockholm |
Product information
20/06/2022 Doptelet - EMEA/H/C/004722 - IA/0013
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
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).