TAVLESSE Film-coated tablet Ref.[27766] Active ingredients: Fostamatinib

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallรจs, 08150 Barcelona Spain

Product name and form

TAVLESSE 100 mg film-coated tablets.

TAVLESSE 150 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

TAVLESSE 100 mg film-coated tablets

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).

TAVLESSE 150 mg film-coated tablets

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 is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK), through its major metabolite R406. R406 reduces antibody-mediated destruction of platelets. Fostamatinib is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients.

List of Excipients

Tablet core:

Mannitol
Sodium hydrogen carbonate
Sodium starch glycolate, (type A)
Povidone (K30)
Magnesium stearate

Film-coating:

Poly(vinyl alcohol)
Titanium dioxide
Macrogol (3350)
Talc
Iron oxide yellow
Iron oxide red

Pack sizes and marketing

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.

Marketing authorization holder

Instituto Grifols, S.A., Can Guasc, 2 – Parets del Vallรจs, 08150 Barcelona – Spain

Marketing authorization dates and numbers

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

Drugs

Drug Countries
TAVLESSE Austria, Estonia, Spain, Finland, Ireland, Lithuania, Poland, United Kingdom

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