The marketing authorisation for Glybera has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Glybera : EPAR - Summary for the public (PDF/558.96 KB)
First published: 29/11/2012
Last updated: 15/06/2016
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|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hyperlipoproteinemia Type I
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This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
uniQure biopharma B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
20/04/2017 Glybera - EMEA/H/C/002145 - S/0057
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.