Glybera

Withdrawn

This medicine's authorisation has been withdrawn

alipogene tiparvovec

Overview

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 Glybera was withdrawn from the Community register of orphan medicinal products by the European Commission in October 2017 at the time of the withdrawal of the marketing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

Reference Number: EMA/670094/2015

Product information

Glybera : EPAR - Product Information

Latest procedure affecting product information: S/0057

20/04/2017

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Glybera : EPAR - All Authorised presentations

Glybera : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Glybera
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002145
• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• 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.

• Marketing authorisation holder:
  uniQure biopharma B.V.

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

• Marketing authorisation issued:
  25/10/2012
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Glybera : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Glybera : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Glybera

AdoptedReference Number: EMA/CHMP/472167/2012

Questions and answers on the refusal of the marketing authorisation for Glybera - Outcome of re-examination

AdoptedReference Number: EMA/CHMP/474562/2011

Questions and answers on the recommendation for the refusal of the marketing authorisation for Glybera

AdoptedReference Number: EMA/CHMP/474562/2011