The marketing authorisation for Osigraft has been withdrawn at the request of the marketing-authorisation holder.
Osigraft : EPAR - Summary for the public (PDF/525 KB)
First published: 21/04/2008
Last updated: 27/07/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Olympus Biotech International Limited
|Date of issue of marketing authorisation valid throughout the European Union||
Raheen Business Park
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.
Drugs for treatment of bone diseases
Bone morphogenetic proteins
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.