InductOs (dibotermin alfa): issues with the manufacturing site
2015.11.23
Active substance: dibotermin alfa
23.11.2015 - European Commission decision
In a decision dated 20 November 2015, the EU Commission has ruled suspension of the marketing authorisation of InductOs®, an implant to support the growth of new bone tissue (C(2002)3366).
26.10.2015 - CHMP recommendation
The European Medicines Agency (EMA) has recommended suspension of the marketing authorisation of InductOs®, an implant to support the growth of new bone tissue.
28.07.2015 - Procedure started
The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding InductOs (dibotermin alfa), a bone protein that is implanted in patients with degenerative disc disease for lumbar interbody fusion and tibia fractures.
Further information
To the risk assessment procedure (available in German only)
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):