Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Osigraft   
Auth. number : EU/1/01/179
INN : eptotermin 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: M05BC02 - Eptotermin alfa
(See WHO ATC Index)
Indication: Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Marketing Authorisation Holder: Olympus Biotech International Limited
Block 2, International Science Centre, National Technology Park, Castletroy, Limerick, Ireland

  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
18/05/2001 Centralised - Authorisation EMEA/H/C/293 (2001)1228 of 17/05/2001
24/07/2001 Centralised - Variation EMEA/H/C/293/I/1, 5, 7
24/07/2001 Centralised - Variation EMEA/H/C/293/I/3
24/07/2001 Centralised - Variation EMEA/H/C/293/I/6
31/07/2001 Centralised - Variation EMEA/H/C/293/I/2
28/01/2002 Centralised - Variation EMEA/H/C/293/I/8
31/07/2002 Centralised - Variation EMEA/H/C/293/I/11
10/09/2002 Centralised - Variation EMEA/H/C/293/I/13
10/09/2002 Centralised - Variation EMEA/H/C/293/I/12
05/10/2002 Centralised - Variation EMEA/H/C/293/I/10 (2002)3371 of 03/10/2002
14/11/2002 Centralised - Variation EMEA/H/C/293/I/14 (2002)4498 of 12/11/2002
14/04/2003 Centralised - Variation EMEA/H/C/293/II/9 (2003)1245 of 08/04/2003
21/11/2003 Centralised - Variation EMEA/H/C/293/I/16
16/12/2003 Centralised - Variation EMEA/H/C/293/II/15
30/03/2004 Centralised - Variation EMEA/H/C/293/II/17
08/06/2004 Centralised - Variation EMEA/H/C/293/II/18
02/08/2004 Centralised - Variation EMEA/H/C/293/II/20
02/08/2004 Centralised - Variation EMEA/H/C/293/II/19
22/09/2004 Centralised - Variation EMEA/H/C/293/II/21
01/06/2005 Centralised - Variation EMEA/H/C/293/II/22
02/06/2005 Centralised - Variation EMEA/H/C/293/II/23
04/07/2005 Centralised - Variation EMEA/H/C/293/II/25 (2005)2088 of 28/06/2005
20/11/2005 Centralised - Variation EMEA/H/C/293/IA/30
28/02/2006 Centralised - Variation EMEA/H/C/293/II/29
03/05/2006 Centralised - Variation EMEA/H/C/293/II/27
03/05/2006 Centralised - Variation EMEA/H/C/293/II/26
24/05/2006 Centralised - Renewal EMEA/H/C/293/R/28 (2006)2118 of 19/05/2006
24/10/2006 Centralised - Variation EMEA/H/C/293/II/31
19/12/2006 Centralised - Variation EMEA/H/C/293/II/32
23/02/2007 Centralised - Variation EMEA/H/C/293/II/35
04/05/2007 Centralised - Variation EMEA/H/C/293/II/33 (2007)2024 of 02/05/2007
25/09/2007 Centralised - Variation EMEA/H/C/293/II/37
05/02/2008 Centralised - Variation EMEA/H/C/293/II/36
04/03/2008 Centralised - Variation EMEA/H/C/293/II/34 (2008)877 of 29/02/2008
04/04/2008 Centralised - Variation EMEA/H/C/293/II/38 (2008)1317 of 02/04/2008
20/05/2008 Centralised - Variation EMEA/H/C/293/IA/39
01/10/2008 Centralised - Variation EMEA/H/C/293/II/40
02/10/2008 Centralised - Variation EMEA/H/C/293/IA/41
09/10/2008 Centralised - Variation EMEA/H/C/293/IA/42
28/04/2009 Centralised - Variation EMEA/H/C/293/II/43
02/07/2009 Centralised - Variation EMEA/H/C/293/II/44
20/07/2009 Centralised - Variation EMEA/H/C/293/IB/46
23/03/2010 Centralised - Variation EMEA/H/C/293/II/48
27/04/2010 Centralised - Variation EMEA/H/C/293/II/50
28/07/2010 Centralised - Variation EMEA/H/C/293/IB/51
Updated with Decision(2011)1508 of 28/02/2011
29/07/2010 Centralised - Variation EMEA/H/C/293/II/47 (2010)5322 of 27/07/2010
21/10/2010 Centralised - Variation EMEA/H/C/293/WS/50
20/01/2011 Centralised - Variation EMEA/H/C/293/WS/57
04/03/2011 Centralised - Variation (2011)1508 of 28/02/2011
17/03/2011 Centralised - Variation EMEA/H/C/293/WS/64/G
23/03/2011 Centralised - Variation EMEA/H/C/293/WS/77/G
31/03/2011 Centralised - Variation EMEA/H/C/293/IA/54
Updated with Decision(2011)6143 of 24/08/2011
04/05/2011 Centralised - Renewal EMEA/H/C/293/R/53 (2011)3093 of 02/05/2011
30/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/293/T/55 (2011)6143 of 24/08/2011
20/10/2011 Centralised - Variation EMEA/H/C/293/IA/56/G
Updated with Decision(2012)3755 of 01/06/2012
29/02/2012 Centralised - Variation EMEA/H/C/293/IA/64/G
Updated with Decision(2012)3755 of 01/06/2012
05/06/2012 Centralised - Variation (2012)3755 of 01/06/2012
22/01/2013 Centralised - Variation EMEA/H/C/293/IB/67
Updated with Decision(2014)1684 of 10/03/2014
28/01/2014 Centralised - Variation EMEA/H/C/293/IG/411/G
Updated with Decision(2014)1684 of 10/03/2014
20/02/2014 Centralised - Variation EMEA/H/C/293/WS/452
Updated with Decision(2014)1684 of 10/03/2014
12/03/2014 Centralised - Variation (2014)1684 of 10/03/2014