OSIGRAFT Powder for suspension for implantation Ref.[9362] Active ingredients: Eptotermin alfa

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

Product name and form

Osigraft 3.3 mg powder for suspension for implantation.

Pharmaceutical Form

Powder for suspension for implantation.

White to off-white granular powder.

Qualitative and quantitative composition

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)

Pack sizes and marketing

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.

Marketing authorization holder

Olympus Biotech International Limited, 40 Upper Mount Street, Dublin 2, Ireland

Tel +353 87 9278653, medicalinfo@olympusbiotech.com

Marketing authorization dates and numbers

EU/1/01/179/001

Date of first authorisation: 18.05.2001
Date of latest renewal: 18.05.2011

Drugs

Drug Countries
OSIGRAFT Austria, Estonia, Lithuania

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