Osigraft

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eptotermin alfa

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Osigraft has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 27/07/2016

Authorisation details

Product details
Name
Osigraft
Agency product number
EMEA/H/C/000293
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
Publication details
Marketing-authorisation holder
Olympus Biotech International Limited
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
17/05/2001
Contact address

Raheen Business Park
Limerick
Ireland

Product information

22/08/2014 Osigraft - EMEA/H/C/000293 - IG/0473/G

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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