Overview

The marketing authorisation for Opgenra has been withdrawn at the request of the marketing-authorisation holder.

Opgenra : EPAR - Summary for the public

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български (BG) (709.65 KB - PDF)

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čeština (CS) (592.56 KB - PDF)

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dansk (DA) (583.5 KB - PDF)

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Deutsch (DE) (590.01 KB - PDF)

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eesti keel (ET) (520.97 KB - PDF)

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ελληνικά (EL) (661.16 KB - PDF)

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français (FR) (524.93 KB - PDF)

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italiano (IT) (525.11 KB - PDF)

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latviešu valoda (LV) (658.97 KB - PDF)

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lietuvių kalba (LT) (552.27 KB - PDF)

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magyar (HU) (583.85 KB - PDF)

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Malti (MT) (672.79 KB - PDF)

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Nederlands (NL) (541.61 KB - PDF)

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polski (PL) (667.42 KB - PDF)

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português (PT) (537.23 KB - PDF)

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română (RO) (553.82 KB - PDF)

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slovenčina (SK) (1.03 MB - PDF)

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slovenščina (SL) (583.13 KB - PDF)

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Suomi (FI) (522.19 KB - PDF)

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svenska (SV) (521.89 KB - PDF)

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Product information

Opgenra : EPAR - Product Information

English (EN) (1.19 MB - PDF)

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български (BG) (1.87 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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español (ES) (1.2 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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čeština (CS) (1.62 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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dansk (DA) (1.2 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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Deutsch (DE) (1.24 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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eesti keel (ET) (1.18 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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ελληνικά (EL) (1.92 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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français (FR) (1.22 MB - PDF)

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hrvatski (HR) (1.24 MB - PDF)

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íslenska (IS) (1.17 MB - PDF)

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italiano (IT) (1.21 MB - PDF)

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latviešu valoda (LV) (1.62 MB - PDF)

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lietuvių kalba (LT) (1.27 MB - PDF)

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magyar (HU) (1.64 MB - PDF)

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Malti (MT) (1.65 MB - PDF)

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Nederlands (NL) (1.24 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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norsk (NO) (1.19 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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polski (PL) (1.63 MB - PDF)

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português (PT) (1.19 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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română (RO) (1.28 MB - PDF)

First published: 04/03/2009Last updated: 14/07/2016
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slovenčina (SK) (2.2 MB - PDF)

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slovenščina (SL) (1.57 MB - PDF)

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Suomi (FI) (1.2 MB - PDF)

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svenska (SV) (1.19 MB - PDF)

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Latest procedure affecting product information: IG/0473/G

01/07/2016

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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)

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български (BG) (552.36 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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español (ES) (464.84 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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čeština (CS) (544.1 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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dansk (DA) (467.77 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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Deutsch (DE) (464.93 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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eesti keel (ET) (464.72 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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ελληνικά (EL) (548.15 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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français (FR) (464.43 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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italiano (IT) (464.27 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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latviešu valoda (LV) (543.63 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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lietuvių kalba (LT) (529.55 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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magyar (HU) (507.79 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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Malti (MT) (544.35 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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Nederlands (NL) (464.48 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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norsk (NO) (622.87 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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polski (PL) (547.05 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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português (PT) (464.65 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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română (RO) (527.4 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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slovenčina (SK) (994.79 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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slovenščina (SL) (476.21 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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Suomi (FI) (464.46 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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svenska (SV) (481.49 KB - PDF)

First published: 15/10/2009Last updated: 14/07/2016
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Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

English (EN) (619.59 KB - PDF)

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български (BG) (818.76 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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español (ES) (499.15 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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čeština (CS) (782.65 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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dansk (DA) (678.87 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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Deutsch (DE) (624.42 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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eesti keel (ET) (609.17 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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ελληνικά (EL) (817.11 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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français (FR) (700.32 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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italiano (IT) (693.06 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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latviešu valoda (LV) (765.09 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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lietuvių kalba (LT) (722.78 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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magyar (HU) (712.62 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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Malti (MT) (761.19 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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Nederlands (NL) (627.42 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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norsk (NO) (622.87 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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polski (PL) (840.43 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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português (PT) (699.86 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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română (RO) (732.14 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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slovenčina (SK) (142.87 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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slovenščina (SL) (605.13 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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Suomi (FI) (604.16 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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svenska (SV) (481.49 KB - PDF)

First published: 03/03/2009Last updated: 14/07/2016
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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
Revision
9

Assessment history

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

English (EN) (665.66 KB - PDF)

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Opgenra : EPAR - Public assessment report

English (EN) (1.28 MB - PDF)

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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)

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More information on Opgenra

Public statement on Opgenra: Withdrawal of the marketing authorisation in the European Union

English (EN) (57.1 KB - PDF)

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Questions and answers on the marketing authorisation for Opgenra

Reference Number: EMEA/CHMP/559257/2008

English (EN) (37.84 KB - PDF)

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