EMA — authorised 9 November 2022
- Marketing authorisation holder: AGIOS NETHERLANDS B.V.
- Status: approved
🇪🇺 Pyrukynd in European Union
EMA authorised Pyrukynd on 9 November 2022
Marketing authorisations
EMA — authorised 9 November 2022
- Application: EMEA/H/C/005540
- Marketing authorisation holder: Agios Netherlands B.V.
- Local brand name: Pyrukynd
- Indication: Pyrukynd is indicated for the treatment of pyruvate kinase deficiency (PK deficiency) in adult patients (see section 4.4).
- Pathway: orphan
- Status: approved
Pyrukynd in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in European Union
Frequently asked questions
Is Pyrukynd approved in European Union?
Yes. EMA authorised it on 9 November 2022; EMA authorised it on 9 November 2022.
Who is the marketing authorisation holder for Pyrukynd in European Union?
AGIOS NETHERLANDS B.V. holds the EU marketing authorisation.