Glybera (alipogene tiparvovec)
ATMPExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- alipogene tiparvovec
- Company
- uniQure biopharma B.V.
- Status
- Expired
- Therapeutic area
- Hyperlipoproteinemia Type I
- EU approval
- Thu 25 Oct 2012
- Designations
- ATMP, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002145
- ATC
- C10AX10
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.