EMA — authorised 2 December 2008
- Status: approved
🇪🇺 Kuvan in European Union
EMA authorised Kuvan on 2 December 2008
Marketing authorisation
Kuvan 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 Kuvan approved in European Union?
Yes. EMA authorised it on 2 December 2008.
Who is the marketing authorisation holder for Kuvan in European Union?
BioMarin is the originator. The local marketing authorisation holder may differ — check the official source linked above.