Glybera

alipogene tiparvovec

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

Name Language First published Last updated
Glybera : EPAR - Summary for the public BG = bălgarski 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public ES = español 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public CS = čeština 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public DA = dansk 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public DE = Deutsch 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public ET = eesti keel 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public EL = elliniká 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public EN = English 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public FR = français 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public IT = italiano 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public LV = latviešu valoda 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public LT = lietuvių kalba 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public HU = magyar 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public MT = Malti 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public NL = Nederlands 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public PL = polski 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public PT = português 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public RO = română 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public SK = slovenčina 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public SL = slovenščina 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public FI = suomi 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public SV = svenska 2012-11-29 2016-06-15
Glybera : EPAR - Summary for the public HR = Hrvatski 2012-11-29 2016-06-15

This EPAR was last updated on 30/10/2017 .

Authorisation details

Product details

Product details for Glybera
NameGlybera
Agency product numberEMEA/H/C/002145
Active substance

alipogene tiparvovec

International non-proprietary name (INN) or common name

alipogene tiparvovec

Therapeutic area Hyperlipoproteinemia Type I
Anatomical therapeutic chemical (ATC) code C10 AX10
Additional monitoring

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

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Glybera
Marketing-authorisation holder

uniQure biopharma B.V.
 

Revision8
Date of issue of marketing authorisation valid throughout the European Union25/10/2012

Contact address:

uniQure biopharma B.V.
Meibergdreef 61
NL-1105 BA Amsterdam
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10
Glybera : EPAR - Product Information HR = Hrvatski 2012-11-29 2017-07-10

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.


Name Language First published Last updated
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  
Glybera : EPAR - All Authorised presentations HR = Hrvatski 2012-11-29  

Name Language First published Last updated
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  
Glybera : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2012-11-29  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Glybera : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-09-03 2017-07-10

Initial marketing-authorisation documents

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Glybera