Glybera

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alipogene tiparvovec

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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

This EPAR was last updated on 30/10/2017

Authorisation details

Product details
Name
Glybera
Agency product number
EMEA/H/C/002145
Active substance
alipogene tiparvovec
International non-proprietary name (INN) or common name
alipogene tiparvovec
Therapeutic area (MeSH)
Hyperlipoproteinemia Type I
Anatomical therapeutic chemical (ATC) code
C10AX10
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

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.

Orphan

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

Publication details
Marketing-authorisation holder
uniQure biopharma B.V. 
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
24/10/2012
Contact address
uniQure biopharma B.V.
Meibergdreef 61
NL-1105 BA Amsterdam
The Netherlands

Product information

20/04/2017 Glybera - EMEA/H/C/002145 - S/0057

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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