EMA — authorised 17 May 2001
- Marketing authorisation holder: Olympus Biotech International Limited
- Status: approved
🇪🇺 Osigraft in European Union
EMA authorised Osigraft on 17 May 2001
Marketing authorisations
EMA — authorised 17 May 2001
- Application: EMEA/H/C/000293
- Marketing authorisation holder: Olympus Biotech International Limited
- Local brand name: Osigraft
- 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.
- Status: withdrawn
EMA — authorised 19 February 2009
- Application: EMEA/H/C/000819
- Marketing authorisation holder: Olympus Biotech International Limited
- Local brand name: Opgenra
- Indication: Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
- Status: withdrawn
Osigraft in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in European Union
Frequently asked questions
Is Osigraft approved in European Union?
Yes. EMA authorised it on 17 May 2001; EMA authorised it on 17 May 2001; EMA authorised it on 19 February 2009.
Who is the marketing authorisation holder for Osigraft in European Union?
Olympus Biotech International Limited holds the EU marketing authorisation.