EMA — authorised 25 October 2012
- Marketing authorisation holder: uniQure biopharma B.V.
- Status: approved
🇪🇺 Glybera in European Union
EMA authorised Glybera on 25 October 2012
Marketing authorisations
EMA — authorised 25 October 2012
- Application: EMEA/H/C/002145
- Marketing authorisation holder: uniQure biopharma B.V.
- Local brand name: Glybera
- Indication: Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.
- Pathway: exceptional circumstances, ATMP
- Status: withdrawn
Glybera 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 Glybera approved in European Union?
Yes. EMA authorised it on 25 October 2012; EMA authorised it on 25 October 2012.
Who is the marketing authorisation holder for Glybera in European Union?
uniQure biopharma B.V. holds the EU marketing authorisation.