EMA — authorised 4 July 2023
- Marketing authorisation holder: TAIHO PHARMA NETHERLANDS B.V.
- Status: approved
🇪🇺 Lytgobi in European Union
EMA authorised Lytgobi on 4 July 2023
Marketing authorisations
EMA — authorised 4 July 2023
- Application: EMEA/H/C/005627
- Marketing authorisation holder: Taiho Pharma Netherlands B.V.
- Local brand name: Lytgobi
- Indication: Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
- Pathway: conditional
- Status: approved
Lytgobi 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 Lytgobi approved in European Union?
Yes. EMA authorised it on 4 July 2023; EMA authorised it on 4 July 2023.
Who is the marketing authorisation holder for Lytgobi in European Union?
TAIHO PHARMA NETHERLANDS B.V. holds the EU marketing authorisation.