Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Medtronic BioPharma B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands, tel +31 (0) 45 566 8000, fax +31 (0) 45 566 8012
InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix.
Pharmaceutical Form |
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Powder, solvent and matrix for implantation matrix. The powder is white. The solvent is a clear colourless liquid. The matrix is white. |
One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Dibotermin alfa |
Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation. Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells. The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time. |
List of Excipients |
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Powder: Sucrose Solvent: Water for injections Matrix: Bovine Type I collagen |
InductOs 4 mg pack contains:
InductOs 12 mg pack contains:
Not all pack sizes may be marketed.
Medtronic BioPharma B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands, tel +31 (0) 45 566 8000, fax +31 (0) 45 566 8012
EU/1/02/226/001
EU/1/02/226/002
Date of first authorisation: 9 September 2002
Date of latest renewal: 20 July 2012
Drug | Countries | |
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INDUCTOS | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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