EMA — authorised 19 November 2020
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Status: approved
🇪🇺 Oxlumo in European Union
EMA authorised Oxlumo on 19 November 2020
Marketing authorisations
EMA — authorised 19 November 2020
- Application: EMEA/H/C/005040
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Local brand name: Oxlumo
- Indication: Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
- Pathway: orphan, PRIME
- Status: approved
Oxlumo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Oxlumo approved in European Union?
Yes. EMA authorised it on 19 November 2020; EMA authorised it on 19 November 2020.
Who is the marketing authorisation holder for Oxlumo in European Union?
Alnylam Netherlands B.V. holds the EU marketing authorisation.