Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: InductOs   
Auth. number : EU/1/02/226
INN : Dibotermin alfa
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M05 - Drugs for treatment of bone diseases
Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization
Chemical subgroup: M05BC - Bone morphogenetic proteins
Chemical substance: M05BC01 - Dibotermin alfa
(See WHO ATC Index)
Indication: InductOs is indicated for single-level (L4 – S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
InductOs isindicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Marketing Authorisation Holder: Medtronic BioPharma B.V.
Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/09/2002 Centralised - Authorisation EMEA/H/C/408 (2002)3366 of 09/09/2002
04/02/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/408/T/1 (2003)464 of 31/01/2003
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/I/3
12/06/2003 Centralised - Variation EMEA/H/C/408/I/2 (2003)1885 of 10/06/2003
24/07/2003 Centralised - Notification EMEA/H/C/408/N/4 (2003)2736 of 22/07/2003
22/01/2004 Centralised - Notification EMEA/H/C/408/N/5 (2004)137 of 20/01/2004
26/02/2004 Centralised - Notification EMEA/H/C/408/N/6 (2004)637 of 23/02/2004
28/09/2004 Centralised - Variation EMEA/H/C/408/II/8 (2004)3648 of 24/09/2004
01/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/10
30/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/12
30/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/9
31/03/2005 Centralised - Variation EMEA/H/C/408/II/7 (2005)1050 of 29/03/2005
15/06/2005 Centralised - Variation EMEA/H/C/408/IA/15
Updated with Decision(2006)504 of 13/02/2006
15/06/2005 Centralised - Variation EMEA/H/C/408/IA/14
Updated with Decision(2006)504 of 13/02/2006
17/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/13
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/18
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/19
19/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/16
15/02/2006 Centralised - Variation (2006)504 of 13/02/2006
31/03/2006 Centralised - Variation EMEA/H/C/408/II/21 (2006)1354 of 29/03/2006
04/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/22
01/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/24
08/08/2006 Centralised - Variation EMEA/H/C/408/II/23 (2006)3641 of 04/08/2006
30/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IB/25
31/08/2006 Centralised - Variation EMEA/H/C/408/II/20 (2006)3937 of 28/08/2006
20/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/26
26/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/27
02/04/2007 Centralised - Variation EMEA/H/C/408/II/28 (2007)1535 of 29/03/2007
10/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/29
05/09/2007 Centralised - Renewal EMEA/H/C/408/R/30 (2007)4178 of 30/08/2007
05/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IA/32, 33
03/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/34
03/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/35
23/06/2008 Centralised - Variation EMEA/H/C/408/II/36 (2008)3085 of 19/06/2008
25/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/37
07/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/38
07/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/39
12/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/40
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IB/42
24/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/43
30/03/2010 Centralised - Variation EMEA/H/C/408/II/41 (2010)2190 of 26/03/2010
19/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IB/46/G
29/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IB/49
10/05/2010 Centralised - Variation EMEA/H/C/408/IB/48
Updated with Decision(2010)6105 of 31/08/2010
02/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/47
03/09/2010 Centralised - Variation EMEA/H/C/408/II/44 (2010)6105 of 31/08/2010
03/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/51/G
09/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/IB/52/G
26/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/53
22/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/54/G
07/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/408/II/56/G
20/06/2011 Centralised - Variation EMEA/H/C/408/WS/117 (2011)4345 of 15/06/2011
10/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/408/T/57 (2011)5833 of 05/08/2011
11/11/2011 Centralised - Variation EMEA/H/C/408/IA/59/G
Updated with Decision(2012)644 of 31/01/2012
03/02/2012 Centralised - Variation (2012)644 of 31/01/2012
25/07/2012 Centralised - Renewal EMEA/H/C/408/R/62 (2012)5286 of 20/07/2012
18/04/2013 Centralised - Variation EMEA/H/C/408/IB/66
Updated with Decision(2014)3364 of 14/05/2014
23/04/2014 Centralised - Notification EMEA/H/C/408/N/72
Updated with Decision(2014)3364 of 14/05/2014
16/05/2014 Centralised - Yearly update (2014)3364 of 14/05/2014