Osigraft

Withdrawn

This medicine's authorisation has been withdrawn

eptotermin alfa

Overview

On 17 December 2015, the European Commission withdrew the marketing authorisation for Osigraft (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. 

Osigraft was granted marketing authorisation in the EU on 17 May 2001 for treatment of non-union of the tibia. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2006. It was then granted unlimited validity in 2011. 

The European Public Assessment Report (EPAR) for Osigraft is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Osigraft : EPAR - Summary for the public

Product information

Osigraft : EPAR - Product Information

Osigraft : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Osigraft
• Active substance:
  eptotermin alfa
• International non-proprietary name (INN) or common name:
  eptotermin alfa
• Therapeutic area (MeSH):
  Tibial Fractures
• Anatomical therapeutic chemical (ATC) code:
  M05BC02

Pharmacotherapeutic group

• Drugs for treatment of bone diseases
• Bone morphogenetic proteins

Therapeutic indication

Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.

Authorisation details

• EMA product number:
  EMEA/H/C/000293
• Marketing authorisation holder:
  Olympus Biotech International Limited

  Raheen Business Park ; Limerick ; Ireland

• Marketing authorisation issued:
  17/05/2001
• Withdrawal of marketing authorisation:
  17/12/2015
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

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

Osigraft : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Osigraft : EPAR - Scientific Discussion

Osigraft : EPAR - Procedural steps taken before authorisation