EMA — authorised 4 May 2023
- Marketing authorisation holder: LES LABORATOIRES SERVIER
- Status: approved
🇪🇺 Tibsovo in European Union
EMA authorised Tibsovo on 4 May 2023
Marketing authorisations
EMA — authorised 4 May 2023
- Application: EMEA/H/C/005936
- Marketing authorisation holder: Les Laboratoires Servier
- Local brand name: Tibsovo
- Indication: Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
- Pathway: orphan
- Status: approved
EMA
- Application: EMEA/H/C/005056
- Marketing authorisation holder: Agios Netherlands B.V.
- Local brand name: Tibsovo
- Indication: Treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) and locally advanced or metastatic cholangiocarcinoma
- Status: withdrawn
EMA
- Application: EMEA/H/C/006174
- Marketing authorisation holder: Les Laboratoires Servier
- Local brand name: Tidhesco
- Indication: Treatment of newly diagnosed acute myeloid leukaemia
- Pathway: orphan
- Status: withdrawn
Tibsovo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Tibsovo approved in European Union?
Yes. EMA authorised it on 4 May 2023; EMA authorised it on 4 May 2023; EMA has authorised it.
Who is the marketing authorisation holder for Tibsovo in European Union?
LES LABORATOIRES SERVIER holds the EU marketing authorisation.