Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallès, 08150 Barcelona Spain
TAVLESSE 100 mg film-coated tablets.
TAVLESSE 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. TAVLESSE 100 mg film-coated tablets: Approximately 9.0 mm round, biconvex, dark orange film-coated tablet debossed “100” on one side and “R” on the other side. TAVLESSE 150 mg film-coated tablets: Approximately 7.25 mm x 14.5 mm oval, biconvex, light orange film-coated tablet debossed “150” on one side and “R” on the other side. |
Each film-coated tablet contains 126.2 mg of fostamatinib disodium hexahydrate equivalent to 100 mg fostamatinib.
Excipient(s) with known effect: Each 100 mg tablet contains 23 mg sodium (from excipients and fostamatinib disodium hexahydrate).
Each film-coated tablet contains 189.3 mg of fostamatinib disodium hexahydrate equivalent to 150 mg fostamatinib.
Excipient(s) with known effect: Each 150 mg tablet contains 34 mg sodium (from excipients and fostamatinib disodium hexahydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fostamatinib |
Fostamatinib mediates its activity effectively through its major metabolite, R406, which is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). R406 inhibits signal transduction of B-cell receptors and Fc-activating receptors, which play a key role in antibody-mediated cellular responses. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets. |
| List of Excipients |
|---|
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Tablet core: Mannitol Film-coating: Poly(vinyl alcohol) |
White high density polyethylene (HDPE) bottle with an aluminium foil tamper evident seal and a white polypropylene (PP) child-resistant cap, together with two white opaque HDPE desiccant canisters containing silica gel.
Pack sizes of 30 and 60 film-coated tablets. Not all pack sizes may be marketed.
Instituto Grifols, S.A., Can Guasc, 2 – Parets del Vallès, 08150 Barcelona – Spain
TAVLESSE 100 mg film-coated tablets: EU/1/19/1405/001
TAVLESSE 150 mg film-coated tablets: EU/1/19/1405/002
Date of first authorisation: 09 january 2020
| Drug | Countries | |
|---|---|---|
| TAVLESSE | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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