Opgenra

RSS

eptotermin alfa

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Opgenra has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 14/07/2016

Authorisation details

Product details
Name
Opgenra
Agency product number
EMEA/H/C/000819
Active substance
eptotermin alfa
International non-proprietary name (INN) or common name
eptotermin alfa
Therapeutic area (MeSH)
Spondylolisthesis
Anatomical therapeutic chemical (ATC) code
M05BC02
Publication details
Marketing-authorisation holder
Olympus Biotech International Limited
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
19/02/2009
Contact address
Block 2
International Science Centre
National Technology Park
Castletroy
Limerick
Ireland

Product information

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

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.

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

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