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The marketing authorisation for Opgenra has been withdrawn at the request of the marketing-authorisation holder.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 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public ES = español 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public CS = čeština 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public DA = dansk 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public DE = Deutsch 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public ET = eesti keel 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public EL = elliniká 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public EN = English 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public FR = français 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public IT = italiano 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public LV = latviešu valoda 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public LT = lietuvių kalba 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public HU = magyar 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public MT = Malti 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public NL = Nederlands 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public PL = polski 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public PT = português 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public RO = română 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public SK = slovenčina 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public SL = slovenščina 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public FI = suomi 2009-03-03 2016-07-14
Opgenra : EPAR - Summary for the public SV = svenska 2009-03-03 2016-07-14

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 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14
Opgenra : EPAR - Product Information SV = svenska 2009-03-03 2016-07-14

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

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

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 2009-10-15 2016-07-14

Initial marketing-authorisation documents

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

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Opgenra