Source: European Medicines Agency (EU) Revision Year: 2016 Publisher: Olympus Biotech International Limited, 40 Upper Mount Street, Dublin 2, Ireland Tel +353 87 9278653, medicalinfo@olympusbiotech.com
Osigraft 3.3 mg powder for suspension for implantation.
| Pharmaceutical Form |
|---|
|
Powder for suspension for implantation. White to off-white granular powder. |
Each vial contains 3.3 mg of eptotermin alfa*.
* Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eptotermin alfa |
Eptotermin alfa, the active substance, initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle. Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process. |
| List of Excipients |
|---|
|
Bovine collagen (vacuum dried) |
Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium).
The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.
Pack size of 1 vial.
Olympus Biotech International Limited, 40 Upper Mount Street, Dublin 2, Ireland
Tel +353 87 9278653, medicalinfo@olympusbiotech.com
EU/1/01/179/001
Date of first authorisation: 18.05.2001
Date of latest renewal: 18.05.2011
| Drug | Countries | |
|---|---|---|
| OSIGRAFT | Austria, Estonia, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
