Opgenra
Withdrawn
This medicine's authorisation has been withdrawn
eptotermin alfa
MedicineHumanWithdrawn
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- 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Assessment Report (EPAR) for Opgenra is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IG/0473/G
01/07/2016
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).
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 diseasesTherapeutic indication
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
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