In other countries
The same active substances on other registers, the same brand first.
Authorised centrally in the EU
This national listing belongs to a medicine the European Commission authorised for the whole EU.
- TibsovoBrazil · Laboratórios Servier do Brasil LtdaSame brand
- TibsovoCanada · 250 MG · Tablet (Immediate-Release) · Servier Canada INCSame brand
- TibsovoEuropean Union · Les Laboratoires ServierSame brand
- TibsovoEuropean Union · Agios Netherlands B.V.Same brand
- TibsovoCroatiaSame brand
- TibsovoItaly · Compressa rivestita con film · Les Laboratoires ServierSame brand
- Tibsovo 250 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Les Laboratoires ServierSame brand
- Tibsovo Film-Coated Tablet 250mgSingapore · 250.0mg · tablet, film coated · Servier (S) Pte LTDSame brand
- TIBSOVO film-coated tablets 250mgTaiwan · 膜衣錠 · 新加坡商施維雅股份有限公司臺灣分公司Same brand
- TibsovoUnited States · 250MG · tablet · ServierSame brand
- TidhescoEuropean Union · Les Laboratoires ServierSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| TIBSOVO 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 60 comprimidos | 764181 |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.
Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Ivosidenib
- Strength
- 250 mg
- Dosage form
- comprimido recubierto con película
- Route
- vía oral
- Register
- Spain (AEMPS)
- Status
- Marketed
- Status in the register
- Autorizado, comercializado
- Authorised
- 5 Feb 2024
- Registration
- 1231728001
- Marketing authorisation holder
- Les Laboratoires Servier
- Procedure
- EU centralised
- Supply
- Diagnóstico Hospitalario
- EU number
- EU/1/23/1728