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Active Substance: alipogene tiparvovec
Common Name: alipogene tiparvovec
ATC Code: C10 AX10
Marketing Authorisation Holder: uniQure biopharma B.V.  
Active Substance: alipogene tiparvovec
Status: Withdrawn
Authorisation Date: 2012-10-25
Therapeutic Area: Hyperlipoproteinemia Type I
Pharmacotherapeutic Group: Lipid modifying agents

Therapeutic 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.

The marketing authorisation for Glybera has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Source: European Medicines Agency

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