Tavlesse

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fostamatinib

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

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.

This EPAR was last updated on 06/07/2020

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 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
Instituto Grifols S.A.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
09/01/2020
Contact address

C/ Can Guasch, 2
Pol. Ind. Levante,
08150 Parets del Vallès
Barcelona
Spain

Product information

22/06/2020 Tavlesse - EMEA/H/C/005012 - IAIN/0003/G

Contents

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Pharmacotherapeutic group

Other systemic hemostatics

Therapeutic indication

Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

Assessment history

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