EMA — authorised 11 February 2021
- Marketing authorisation holder: SEAGEN B.V
- Status: approved
🇪🇺 Tukysa in European Union
EMA authorised Tukysa on 11 February 2021
Marketing authorisations
EMA — authorised 11 February 2021
- Application: EMEA/H/C/005263
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Tukysa
- Indication: Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.
- Status: approved
Tukysa 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 Tukysa approved in European Union?
Yes. EMA authorised it on 11 February 2021; EMA authorised it on 11 February 2021.
Who is the marketing authorisation holder for Tukysa in European Union?
SEAGEN B.V holds the EU marketing authorisation.