European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is TB-500 (thymosin beta-4 fragment) legal in European Union?
Not approvedNot authorised as a medicine in the EU; banned in sport (WADA S2.3)
Not approved as a medicine here.
TB-500 has no EU marketing authorisation and does not appear in the EMA dataset or Union Register. If it is offered for use in people it falls within the EU definition of a medicinal product and would need authorisation first. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names thymosin-beta4 and its derivatives, for example TB-500, under S2.3 (growth factors and modulators).
Last verified 2026-09-29 · how we verify
TB-500 (thymosin beta-4 fragment) elsewhere
Sources (3)
- 01EMA medicines data (JSON report): human and veterinary medicines, with authorisation statusEuropean Medicines Agency · 2026-09-29 · accessed 2026-09-29
- 02Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)European Union (EUR-Lex) · 2025-01-01 · accessed 2026-09-29
- 03The 2026 Prohibited ListWorld Anti-Doping Agency · 2025-09 · accessed 2026-09-29