Osigraft
Withdrawn
This medicine's authorisation has been withdrawn
eptotermin alfa
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Osigraft has been withdrawn at the request of the marketing-authorisation holder.
Osigraft : EPAR - Summary for the public
English (EN) (525 KB - PDF)
First published: Last updated:
български (BG) (688.37 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
español (ES) (526.68 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
čeština (CS) (595.92 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
dansk (DA) (543.34 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Deutsch (DE) (528.06 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
eesti keel (ET) (590.8 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
ελληνικά (EL) (697.3 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
français (FR) (590.51 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
italiano (IT) (527.93 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
latviešu valoda (LV) (601.7 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
lietuvių kalba (LT) (616.86 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
magyar (HU) (588.52 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Malti (MT) (693.71 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Nederlands (NL) (1.03 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
polski (PL) (658.42 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
português (PT) (589.41 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
română (RO) (556.33 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
slovenčina (SK) (653.58 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
slovenščina (SL) (587.38 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Suomi (FI) (527.19 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
svenska (SV) (586.38 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Product information
Osigraft : EPAR - Product Information
English (EN) (826.02 KB - PDF)
First published: Last updated:
български (BG) (1.25 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
español (ES) (737.28 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
čeština (CS) (1.08 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
dansk (DA) (780.64 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Deutsch (DE) (749.16 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
eesti keel (ET) (781.57 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
ελληνικά (EL) (1.28 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
français (FR) (834.64 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
hrvatski (HR) (826.45 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
íslenska (IS) (782.74 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
italiano (IT) (790.55 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
latviešu valoda (LV) (1.1 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
lietuvių kalba (LT) (808.63 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
magyar (HU) (1.07 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Malti (MT) (1.11 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Nederlands (NL) (1.27 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
norsk (NO) (740.13 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
polski (PL) (1.1 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
português (PT) (790.71 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
română (RO) (831.09 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
slovenčina (SK) (1.08 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
slovenščina (SL) (1.06 MB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Suomi (FI) (736.32 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
svenska (SV) (894.02 KB - PDF)
First published: 21/04/2008Last updated: 27/07/2016
Latest procedure affecting product information:
IG/0473/G
22/08/2014
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).
Osigraft : EPAR - All Authorised presentations
English (EN) (461.49 KB - PDF)
First published: Last updated:
български (BG) (563.36 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
español (ES) (462.05 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
čeština (CS) (555.73 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
dansk (DA) (462.37 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
Deutsch (DE) (461.98 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
eesti keel (ET) (461.83 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
ελληνικά (EL) (558.09 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
français (FR) (461.63 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
hrvatski (HR) (47.54 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
íslenska (IS) (462.01 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
italiano (IT) (461.37 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
latviešu valoda (LV) (555.63 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
lietuvių kalba (LT) (542.27 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
magyar (HU) (513.66 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
Malti (MT) (558.05 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
Nederlands (NL) (910.31 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
norsk (NO) (461.91 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
polski (PL) (558.37 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
português (PT) (462.62 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
română (RO) (539.19 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
slovenčina (SK) (554.57 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
slovenščina (SL) (473.79 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
Suomi (FI) (461.9 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
svenska (SV) (462.14 KB - PDF)
First published: 21/10/2005Last updated: 27/07/2016
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
- Revision
- 13
Assessment history
Osigraft : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (734.08 KB - PDF)
First published: Last updated:
Osigraft : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (542.25 KB - PDF)
First published: Last updated:
More information on Osigraft
Public statement on Osigraft: Withdrawal of the marketing authorisation in the European Union
English (EN) (94.5 KB - PDF)
First published: Last updated:
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