Is Fostamatinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Fostamatinib, including TAVALISSE (Prescription); FOSTAMATINIB DISODIUM (Prescription).

Is Fostamatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fostamatinib: Tavlesse.

Active substance

Fostamatinib

US FDA 2
EMA 1
Health Canada 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TAVALISSE	EQ 100MG BASE; EQ 150MG BASE	tablet · oral	RIGEL PHARMS	Prescription	17 Apr 2018
FOSTAMATINIB DISODIUM	EQ 100MG BASE; EQ 150MG BASE	tablet · oral	ANNORA PHARMA	Prescription	17 Jun 2026

EMA European Union — centrally authorised medicines

Tavlesse Instituto Grifols S.A. · Authorised · authorised 9 Jan 2020 · ATC B02BX

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TAVALISSE	02508052	100 MG	TABLET · ORAL	MEDISON PHARMA CANADA INC.
TAVALISSE	02508060	150 MG	TABLET · ORAL	MEDISON PHARMA CANADA INC.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.