Opgenra

RSS
Withdrawn

This medicine's authorisation has been withdrawn

eptotermin alfa
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 1 July 2016, the European Commission withdrew the marketing authorisation for Opgenra (eptotermin alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Olympus Biotech International Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Opgenra was granted marketing authorisation in the EU on 19 February 2009 for treatment of spondylolisthesis. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2013. 

The European Public Assessment Report (EPAR) for Opgenra is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Opgenra : EPAR - Summary for the public

English (EN) (520.19 KB - PDF)

First published: Last updated:
View

български (BG) (709.65 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

español (ES) (582.84 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

čeština (CS) (592.56 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

dansk (DA) (583.5 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

Deutsch (DE) (590.01 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

eesti keel (ET) (520.97 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

ελληνικά (EL) (661.16 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

français (FR) (524.93 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

italiano (IT) (525.11 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

latviešu valoda (LV) (658.97 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

lietuvių kalba (LT) (552.27 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

magyar (HU) (583.85 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

Malti (MT) (672.79 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

Nederlands (NL) (541.61 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

polski (PL) (667.42 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

português (PT) (537.23 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

română (RO) (553.82 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

slovenčina (SK) (1.03 MB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

slovenščina (SL) (583.13 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

Suomi (FI) (522.19 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

svenska (SV) (521.89 KB - PDF)

First published: 04/03/2009 Last updated: 15/07/2016
View

Product information

Opgenra : EPAR - Product Information

English (EN) (1.19 MB - PDF)

First published: Last updated:
View

български (BG) (1.87 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

español (ES) (1.2 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

čeština (CS) (1.62 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

dansk (DA) (1.2 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

Deutsch (DE) (1.24 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

eesti keel (ET) (1.18 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

ελληνικά (EL) (1.92 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

français (FR) (1.22 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

hrvatski (HR) (1.24 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

íslenska (IS) (1.17 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

italiano (IT) (1.21 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

latviešu valoda (LV) (1.62 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

lietuvių kalba (LT) (1.27 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

magyar (HU) (1.64 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

Malti (MT) (1.65 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

Nederlands (NL) (1.24 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

norsk (NO) (1.19 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

polski (PL) (1.63 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

português (PT) (1.19 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

română (RO) (1.28 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

slovenčina (SK) (2.2 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

slovenščina (SL) (1.57 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

Suomi (FI) (1.2 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View

svenska (SV) (1.19 MB - PDF)

First published: 04/03/2009 Last updated: 14/07/2016
View
Latest procedure affecting product information:IG/0473/G
01/07/2016
icon globe

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).

Opgenra : EPAR - All Authorised presentations

English (EN) (464.09 KB - PDF)

First published: Last updated:
View

български (BG) (552.36 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

español (ES) (464.84 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

čeština (CS) (544.1 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

dansk (DA) (467.77 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

Deutsch (DE) (464.93 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

eesti keel (ET) (464.72 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

ελληνικά (EL) (548.15 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

français (FR) (464.43 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

italiano (IT) (464.27 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

latviešu valoda (LV) (543.63 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

lietuvių kalba (LT) (529.55 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

magyar (HU) (507.79 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

Malti (MT) (544.35 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

Nederlands (NL) (464.48 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

norsk (NO) (622.87 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

polski (PL) (547.05 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

português (PT) (464.65 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

română (RO) (527.4 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

slovenčina (SK) (994.79 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

slovenščina (SL) (476.21 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

Suomi (FI) (464.46 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

svenska (SV) (481.49 KB - PDF)

First published: 15/10/2009 Last updated: 14/07/2016
View

Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

English (EN) (619.59 KB - PDF)

First published: Last updated:
View

български (BG) (818.76 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

español (ES) (499.15 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

čeština (CS) (782.65 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

dansk (DA) (678.87 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

Deutsch (DE) (624.42 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

eesti keel (ET) (609.17 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

ελληνικά (EL) (817.11 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

français (FR) (700.32 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

italiano (IT) (693.06 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

latviešu valoda (LV) (765.09 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

lietuvių kalba (LT) (722.78 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

magyar (HU) (712.62 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

Malti (MT) (761.19 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

Nederlands (NL) (627.42 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

norsk (NO) (622.87 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

polski (PL) (840.43 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

português (PT) (699.86 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

română (RO) (732.14 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

slovenčina (SK) (142.87 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

slovenščina (SL) (605.13 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

Suomi (FI) (604.16 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

svenska (SV) (481.49 KB - PDF)

First published: 03/03/2009 Last updated: 14/07/2016
View

Product details

Name of medicine
Opgenra
Active substance
eptotermin alfa
International non-proprietary name (INN) or common name
eptotermin alfa
Therapeutic area (MeSH)
Spondylolisthesis
Anatomical therapeutic chemical (ATC) code
M05BC02

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.

Authorisation details

EMA product number
EMEA/H/C/000819
Marketing authorisation holder
Olympus Biotech International Limited

Block 2
International Science Centre
National Technology Park
Castletroy
Limerick
Ireland

Marketing authorisation issued
19/02/2009
Withdrawal of marketing authorisation
01/07/2016
Revision
9

Assessment history

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

English (EN) (665.66 KB - PDF)

First published: Last updated:
View

Opgenra : EPAR - Public assessment report

English (EN) (1.28 MB - PDF)

First published: Last updated:
View

Committee for medicinal products for human use, summary of positive opinion for Opgenra

Reference Number: EMEA/CHMP/558609/2008

English (EN) (486.87 KB - PDF)

First published: Last updated:
View

More information on Opgenra

Questions and answers on the marketing authorisation for Opgenra

Reference Number: EMEA/CHMP/559257/2008

English (EN) (37.84 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page