Tavlesse
fostamatinib
Table of contents
Overview
Tavlesse is a medicine for treating adults with chronic immune thrombocytopenia. It is for use when other treatments have not worked.
Chronic immune thrombocytopenia, previously called idiopathic thrombocytopenic purpura (ITP), is a long-term condition in which the immune system (the body’s defences) destroys healthy platelets in the blood. Platelets are needed to form clots and stop bleeding. Patients with the disease have low platelet counts and may bruise or bleed easily.
Tavlesse contains the active substance fostamatinib.
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Tavlesse : EPAR - Medicine overview (PDF/119.51 KB)
First published: 11/02/2020
EMA/628301/2019 -
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Tavlesse : EPAR - Risk-management-plan summary (PDF/283.85 KB)
First published: 11/02/2020
Authorisation details
Product details | |
---|---|
Name |
Tavlesse
|
Agency product number |
EMEA/H/C/005012
|
Active substance |
Fostamatinib disodium
|
International non-proprietary name (INN) or common name |
fostamatinib
|
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 |
Instituto Grifols S.A.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
09/01/2020
|
Contact address |
C/ Can Guasch, 2 |
Product information
09/09/2022 Tavlesse - EMEA/H/C/005012 - IB/0014
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
Therapeutic indication
Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.