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 |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
20/06/2019
|
Contact address |
Product information
18/01/2021 Doptelet - EMEA/H/C/004722 - II/0004/G
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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).