The marketing authorisation for Glybera has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
This product was originally designated an orphan medicine on 8 March 2004. Glybera was withdrawn from the Community register of orphan medicinal products by the European Commission in October 2017 at the time of the withdrawal of the marketing authorisation.
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.
uniQure biopharma B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
uniQure biopharma B.V.
NL-1105 BA Amsterdam
20/04/2017 Glybera - EMEA/H/C/002145 - S/0057
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Lipid modifying agents
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.