Opgenra

eptotermin alfa

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The marketing authorisation for Opgenra has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Opgenra : EPAR - Summary for the public BG = bălgarski 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public ES = español 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public CS = čeština 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public DA = dansk 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public DE = Deutsch 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public ET = eesti keel 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public EL = elliniká 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public EN = English 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public FR = français 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public IT = italiano 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public LV = latviešu valoda 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public LT = lietuvių kalba 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public HU = magyar 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public MT = Malti 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public NL = Nederlands 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public PL = polski 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public PT = português 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public RO = română 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public SK = slovenčina 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public SL = slovenščina 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public FI = suomi 03/03/2009 14/07/2016
Opgenra : EPAR - Summary for the public SV = svenska 03/03/2009 14/07/2016

This EPAR was last updated on 14/07/2016 .

Authorisation details

Product details

Product details for Opgenra
NameOpgenra
Agency product numberEMEA/H/C/000819
Active substance

eptotermin alfa

International non-proprietary name (INN) or common name

eptotermin alfa

Therapeutic area Spondylolisthesis
Anatomical therapeutic chemical (ATC) code M05BC02

Publication details

Publication details for Opgenra
Marketing-authorisation holder

Olympus Biotech International Limited

Revision9
Date of issue of marketing authorisation valid throughout the European Union19/02/2009

Contact address:

Olympus Biotech International Limited
Block 2
International Science Centre
National Technology Park
Castletroy
Limerick
Ireland

Product information

Product information

01/07/2016  Opgenra -EMEA/H/C/000819 -IG/0473/G

Name Language First published Last updated
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Product Information SV = svenska 03/03/2009 14/07/2016

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
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016
Opgenra : EPAR - All Authorised presentations SV = svenska 15/10/2009 14/07/2016

Name Language First published Last updated
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016
Opgenra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 03/03/2009 14/07/2016

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Opgenra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 15/10/2009 14/07/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Opgenra : EPAR - Public assessment report SV = svenska 03/03/2009 14/07/2016
Committee for medicinal products for human use, summary of positive opinion for Opgenra SV = svenska 23/10/2008 14/07/2016

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Opgenra